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U.S. Department of Health and Human Services

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515 Project Status

Task A: FDA collects existing information and assesses the risks and benefits (See Docket FDA-2009-M-0101 for information submitted to FDA by manufacturers of these device types)

Task B: FDA convenes a meeting of the advisory committee (panel) to request input on the classification of the device type.

Task C: FDA issues proposed order, which proposes classification of device type into Class I, II, or III

Task D: FDA reviews and considers comments provided

Task E: FDA issues final order, which finalizes classification of device type into Class I, II, or III

DeviceCFRProduct CodesTasks CompletedRecent FDA
Information
automated external defibrillator870.5310MKJ, NSAA, B, C, DProposed Order
Panel Meeting
cranial electrotherapy stimulator882.5800JXKA, B, C, DProposed Order
Panel Meeting
electroconvulsive therapy device882.5940GXCA, BPanel Meeting
endosseous dental implant (blade-form dental implants)872.3640(b)(2)NRQA, B, C, DProposed Order
Panel Meeting
external cardiac compressor870.5200DRM, LIXA, B, C, DProposed Order
Panel Meeting
external pacemaker pulse generator870.3600DTEA, BProposed Rule
Guidance Document
Panel Meeting
hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis888.3330KWAA, B, C, DProposed Order
hip joint metal/metal semi-constrained, with cemented acetabular component, prosthesis888.3320JDL, LTOA, B, C, DProposed Order
implanted blood access device876.5540(b)(1)MSDA, B, CProposed Order
Guidance Document
Panel Meeting
iontophoresis device890.5525(b)EGJA, BPanel Meeting
membrane lung for long-term pulmonary support (i.e., ECMO)868.5610BYSA, B, CProposed Order
Panel Meeting
nonroller-type cardiopulmonary bypass blood pump870.4360KFMA, B, CProposed Order
Panel Meeting
pedicle screw spinal system888.3070(b)(2)NKBA, BPanel Meeting
shortwave diathermy890.5290(b)ILXA, B, CProposed Order
Panel Meeting

 

Finalized 515 Projects

YearDeviceCFRProduct CodeFinal
Classification
of Device
Class IIIReclassification
(Class III to Class II or Class I)
check mark Totalcheck markTotal
2011topical oxygen878.5650KPJFinal Rule1 3check mark1
female condom884.5330OBYFinal Rule1check mark 
pacemaker repair or replacement material870.3710KFJFinal Rule1check mark 
ventricular bypass device870.3545OKRFinal Rule1check mark 
2012implantable pacemaker pulse generator870.3610DSZ, DXYFinal Rule1check mark3 0
pacemaker programmers870.3700KRGFinal Rule1check mark 
cardiovascular permanent pacemaker electrode870.3680(b)DTBFinal Rule1check mark 
2013temporary mandibular condyle reconstruction plate872.4770NEIFinal Order
Guideline Document
 2check mark 3
intra-aortic balloon and control system870.3535DSPFinal Order2check markcheck mark
external counter-pulsating devices870.5225DRNFinal Order2check markcheck mark
2014transilluminator for breast evaluation892.1990LEKFinal Order2check mark2 1
sorbent hemoperfusion system876.5870FLDFinal Order2check markcheck mark

Please visit the 515 Initiative Website for more information about the program.

1 The classification of this device was finalized prior enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012.

2 Some devices have been classified in two different classes based on the device’s indications for use or technology.