About FDA

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
cranial electrotherapy stimulator882.5800JXKA, B, CProposed Order
Panel Meeting

Finalized 515 Projects

YearDeviceCFRProduct CodeFinal
of Device
Class IIIReclassification
(Class III to
Class II or
Class I)
check markTotalcheck 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 3
sorbent hemoperfusion system876.5870FLDFinal Order2check markcheck mark
endosseous dental implant (blade-form)872.3640NRQFinal Order check mark
implanted blood access876.5540(b)(1)MSDFinal Order
Guidance Document
 check mark
2015automated external defibrillators870.5310MKJ, NSAFinal Ordercheck mark2 2
nonroller-type blood pump870.4360KFMFinal Ordercheck markcheck mark
Nonthermal Shortwave Therapy890.5290(b)ILXFinal Order check mark
2016Extracorporeal Circuit & Accessories for Long-term Respiratory /Cardiopulmonary Failure4870.4100BYSFinal Order 2check mark 5
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prothesis888.3330KWAFinal Ordercheck mark  
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis888.3320JDLFinal Ordercheck mark  
External pacemaker pulse generator870.3600DTEFinal Order check mark
External cardiac compressor5870.5200DRMFinal Order check mark
Iontophoresis890.5525(b)EGJFinal Order check mark
Thoracolumbosacral Pedicle Screw Systems, including semi-rigid systems6888.3070(b)(2)NKB, NQPFinal Order7 check mark
2018electroconvulsive therapy device882.5940GXCFinal Order check mark 1check mark 1

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.

3 CDRH has issued draft guidance on this topic. When finalized, this guidance will represent FDA's current thinking on this topic.

4 This was previously referred to as 'membrane lung for long-term pulmonary support' in 21 CFR 868.5610 and has been redesignated as noted.

5 A separate classification regulation for a subgroup of devices previously within this classification regulation, referred to as cardiopulmonary resuscitation (CPR) aids, was also created and these devices were also reclassified (21 CFR 870.5210).

6 This was previously referred to as 'pedicle screw systems' only and has been redesignated as noted. Semi-rigid systems were previously referred to as 'dynamic stabilization systems'

7 Federal Register Notice with correction of the compliance date for submitting 510(k) amendments.

Page Last Updated: 12/21/2018
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