Medical Devices

File Layout for Releasable 510(k)s

(Format Updated 2/20/2014)


510(K) NUMBER

APPLICANT

CONTACT

STREET 1

STREET 2

CITY

STATE

DOMESTIC ZIP

DEVICE NAME

DATE RECEIVED

DECISION DATE

DECISION

ADVISORY COMMITTEE

PRODUCT CODE

Contains either "SUMMARY" or "STATEMENT"

SUMMARY indicates that a summary of safety and effectiveness information is available from FDA

STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant

Advisory Committee Code under which the product was classified, based on the product code

Blank

Denotes the type of 510(k) submission:

Traditional

Special

Abbreviated

Evaluation of Automatic Class III Designation

THIRD PARTY FLAG - Y or N - Indicates if the 510(k) was reviewed by a Third Party

EXPEDITED REVIEW FLAG - Y, N or null - Indicates if the 510(k) was granted expedited review status.

COUNTRY CODE

FOREIGN POSTAL CODE


510(k) DECISION CODES Substantially Equivalent Codes

KD Substantially Equivalent - Kit with Drugs

PR Substantially Equivalent - Proposed Recision

PT Substantially Equivalent - Subject to Tracking & PMS

RN Substantially Equivalent - Rescind Non-Substantial Equivalence

SA Substantially Equivalent - Awaiting Device Approval

SD Substantially Equivalent with Drug

SE Substantially Equivalent

SF Substantially Equivalent - Awaiting Future Policies

SI Substantially Equivalent - Market after Inspection

SK Substantially Equivalent - Kit

SN Substantially Equivalent for Some Indications

SP Substantially Equivalent - PostMarket Surveillance Required

ST Substantially Equivalent - Subject to Tracking Reg.

SU Substantially Equivalent - With Limitations

SW Substantially Equivalent - Awaiting Drug Approval


Non-Substantially Equivalent Codes

FB Subject to 515(b) - Requires PMA

NE Not Substantially Equivalent

SC Not Substantially Equivalent - Cannot Market

SL Not Substantially Equivalent - Improper Label

RE Rescind Substantial Equivalence

UD Unable to Determine Equivalence

UO Unable to Determine Equivalence - Outstanding Drug Issue

UR Not Substantially Equivalent - Unreliable Data

OD Unable to Determine Equivalence - Outstanding Device Issue


Other Decision Codes

CR Additional Information Requested; Applicant can not respond within 30 days

DB Forwarded to Drugs/Biologics

DD Deleted/Duplicate

DE Deleted

DR Drug (CDER) Review Required

EX Exempted by Regulation

GP General Purpose Article

K4 Closeout Letter Issued

NA Not Actively Regulated

ND Not a Device

NF Not a Finished Product

NR Not a Required Submission

PE Preamendment Exempt

RC Reconditioner/Remanufacturer

TR Transitional Device

WD Withdrawn by Applicant

Page Last Updated: 06/17/2014
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