Medical Devices

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - March 2015

Section VI. of FDA’s Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling outlines six criterion that should be addressed in reprocessing instructions. Criterion 4 recommends that reprocessing instructions should include devices and accessories that are legally marketed. On this page is a table of FDA-cleared liquid chemical sterilants and high level disinfectants, last updated September 2015.

Manufacturer Active Ingredient(s) Sterilant Contact Conditions High Level
Disinfectant Contact Conditions
K091210 Acecide-C High Level Disnfectant and Sterilant
Best Sanitizers, Inc. 3100-3400 ppm peracetic acid

Indication for device sterilization
2 hrs at 20ºC
5 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.
 

7 min at 20ºC
5 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
 
K091890 Extended Use Aldahol High Level Disinfectant
Healthpoint, Ltd. 3.4% glutaraldehyde
20.1% isopropanol
 

Indication for device sterilization
For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC:
6 hrs at 25ºC
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.
 

For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC:
5 min at 25ºC
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
 
K091022 Resert XL HLD High Level Disinfectant
Steris Corporation 2.0% hydrogen peroxide

No indication for device sterilization.
Passes the Modified AOAC Sporicidal Activity Test in 6 hrs at 20ºC.
 

8 min at 20ºC
21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
 

K090036 Steris S40 Sterilant Concentrate
Note: Cleared for use with the Steris System 1E Liquid Chemical Sterilant Processing System

Steris Corporation ≥1820 mg/L peracetic acid

Indication for device sterilization
6 min at 46-55°C Single use – diluted by system
For use in the Steris System 1E Liquid Chemical Sterilant Processing System only
Contact conditions based on AOAC Sporicidal Activity Test and simulated use testing with endoscopes.

No indication for high level disinfection
K113015 Aldahol V High Level Disinfectant
Microchem Laboratories, Inc. 3.4% glutaraldehyde
20.1% isopropanol
 

Indication for device sterilization.
8 hrs at 20ºC
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.
 

10 min at 20ºC
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
 
K120306 Rapicide OPA-28 High Level Disinfectant 
Minntech Corporation 0.575% ortho-phthalaldehyde

No indication for device sterilization.
Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 20ºC and 25°C.

For Manual Processing:
10 min at 20ºC
28 days Maximum Reuse
For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC:
5 min at 25ºC
28 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
 
K140703 OPA 30 Solution
Ciden Technologies, LLC 0.6% ortho-phthalaldehyde No indication for device sterilization.
Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C.

For Manual Processing:
12 min at 20ºC
30 days Maximum Reuse
For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC:
5 min at 25ºC
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
 

K041984 Acecide High Level Disnfectant and Sterilant
Best Sanitizers, Inc. 3300-3800 ppm peracetic acid No indication for device sterilization.
5 hrs at 25°C
5 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.
 
5 min at 25ºC
5 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
 
K051305  TD-5 High-level Disinfectant
CS Medical, L.L.C. 2.65% glutaraldehyde

No indication for device sterilization.

Passes the AOAC Sporicidal Activity Test in 10 hrs at 22 °C.

5 min at 37.8ºC
Single use to be used exclusively with the TD-100 Transesophageal Probe Disinfector.
Contact conditions established by simulated use testing with endoscopes.
K041360 Aldahol III High Level Disinfectant
Healthpoint LTD 3.4% glutaraldehyde
26% isopropanol

Indication for device sterilization.

10 hrs at 20° C
Contact conditions based on AOAC Sporicidal Activity Test only.

10 min at 20ºC
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K012889 Banicide Advanced for Sterilization and High Level Disinfection
Pascal Company, Inc. 3.5% glutaraldehyde

Indication for device sterilization.

10 hrs at 25°C
30 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.

45 min at 25°C
30 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K032959 Cidex® OPA Concentrate
Advanced Sterilization Products 5.75% ortho-phthaldehyde (OPA)

No indication for device sterilization.

In-Use solution (0.05% OPA) passes the AOAC Sporicidal Activity Test in 32 hrs at 50°C.

5 min at 50ºC
Single use – diluted by system
For use in the EvoTech Integrated Endoscope Disinfection System only.
Contact conditions established by simulated use testing with endoscopes.
K030004 Cidex OPA Solution
Advanced Sterilization Products 0.55% ortho-phthaldehyde No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C.

Manual Processing
12 min at 20°C
14 days Maximum Reuse

Automated Endoscope Reprocessor (AER)
5 min at 25°C
14 days Maximum Reuse
(For processing in an AER only with FDA-cleared capability to maintain solution temperature at 25°C.) Contact conditions established by simulated use testing with endoscopes.

K013280 Sterilox Liquid High Level Disinfectant System
Sterilox, Technologies, Inc. Hypochlorite and
Hypochlorous acid 650-675 ppm Active free chlorine
No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 24 hrs at 25°C. 10 min at 25°C
Single use - generated on site
Contact conditions established by simulated use testing with endoscopes.
K003087 Sporicidin Sterilizing and Disinfecting Solution
Sporicidin International 1.12% glutaraldehyde
1.93% phenol/phenate
Indication for device sterilization.
12 hrs at 25°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
20 min at 25°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K993042 Rapicide High Level Disinfectant and Sterilant
MediVators, Inc. 2.5% glutaraldehyde Indication for device sterilization.
7 hrs 40 min at 35°C
28 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes and additional supporting information.
Automated Endoscope Reprocessor
5.0 min at 35°C
28 days Maximum Reuse
(For processing in an AER only with FDA-cleared capability to maintain the solution temperature at 35°C.)
Contact conditions established by simulated use testing with endoscopes.
K991487 °Cidex®OPA Solution High Level Disinfectant
Advanced Sterilization Products 0.55% ortho-phthaldehyde No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C. 12 min at 20°C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974188 °Cetylcide-G Concentrate and Diluent Concentrate
Cetylite Industries, Inc. 3.2% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
40 min at 20°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974062 MedSci 3% Glutaraldehyde
MedSci, Inc. 3% glutaraldehyde Indication for device sterilization. 10 hrs at 25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
25 min at 25°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K972708 EndoSpor Plus Sterilizing and Disinfecting Solution
Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days.
Cottrell Limited 7.35% hydrogen peroxide
0.23% peracetic acid
Indication for device sterilization.
180 min at 20°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
15 min at 20°C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K970230 SporoxTM Sterilizing & Disinfection Solution
Reckitt & Colman Inc. 7.5% hydrogen peroxide Indication for device sterilization.
6 hrs at 20°C
21 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
30 min at 20°C
21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K960513 PeractTM 20 Liquid Sterilant/Disinfectant
Minntech Corporation 1.0% hydrogen peroxide
0.08% peracetic acid
Indication for device sterilization.
8 hrs at 20°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
25 min at 20°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K932922 Procide 14 N.S.
Cottrell Limited 2.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 20°C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 OmnicideTM Long Life Activated Dialdehyde Solution
Cottrell Limited 2.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 20°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 OmnicideTM Plus
Cottrell Limited 3.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 20°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K931592 Metricide Plus 30 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc. 3.4% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide Plus as identical to Cidex Plus.
90 min at 25°C
28 days Maximum Reuse
FDA accepted Metricide Plus as identical to Cidex Plus.
K931052 Metricide 28 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc. 2.5% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide 28 as identical to Cidex Formula 7.
90 min at 25°C
28 days Maximum Reuse
FDA accepted Metricide 28 as identical to Cidex Formula 7.
K930284 Metricide Activated Dialdehyde Solution
Metrex Research, Inc. 2.6% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide as identical to Cidex.
45 min at 25°C
14 days Maximum Reuse
FDA accepted Metricide as identical to Cidex.
K924434 Cidex™ Activated Dialdehyde Solution
Johnson & Johnson Medical Products 2.4% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 25°C
14 days Maximum Reuse Contact conditions based on literature references.
K924334 Cidex Formula 7™ Long-Life Activated Dialdehyde Solution
Johnson & Johnson Medical Products 2.5% glutaraldehyde Indication for device sterilization.
10 hrs at 20-25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
90 min at 25°C
28 days Maximum Reuse
Contact conditions based on literature references.
K923744 Cidex PlusTM 28 Day Solution
Johnson & Johnson Medical Products 3.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20-25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
20 min at 25°C
28 days Maximum Reuse Contact conditions based on literature references.
K914749 Wavicide - 01
Wave Energy Systems 2.5% glutaraldehyde Indication for device sterilization.
10 hrs at 22°C
30 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 22°C
30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K080420 Resert XL HLD High Level Disnfectant
Steris Corporation 2.0% Hydrogen peroxide No indication for device sterilization.
In-Use solution passes the AOAC Sporicidal Activity Test in 6 hrs at 20 °C
8 min at 20ºC
21 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K070627 Opaciden Solution
Ciden Technologies, LLC

0.60% ortho-phthalaldehyde (OPA)

 

No indication for device sterilization.
In-Use solution passes the AOAC Sporicidal Activity Test in 32 hrs at 21 ° C and 32 hrs at 25-27°C.
For Manual Processing:
12 min at 20ºC
14 days Maximum Reuse
For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC:
5 min at 25ºC
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K063159 Sterilox High Level Disinfectant System
Sterilox, Technologies, Inc. Hypochlorous acid/hypochlorite
400-450 ppm Active free chlorine
No indication for device sterilization.
Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 30 ° C.
10 min at 30ºC
Single use - generated on site
Contact conditions established by simulated use testing with endoscopes.
K060618 Cidex Activated Dialdehyde Solution
Advanced Sterilization Products 2.4% glutaraldehyde 10 hrs at 25 °C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.
45 min at 25 °C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.

Page Last Updated: 09/02/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English