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Information on Releasable 510(k)s

See Related Information

General Information

  • 510(k) Overview
Text  
  • Class I 510(k) Exemptions, FDA Talk Paper - February 6, 1996
Text  
  • The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
Text PDF
  • Screening Checklist for all Premarket Notification 510(k) Submissions
Text PDF
  • Reclassification Letters
Text  
  • FDA Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices
Text  

Federal Register Notices

  • Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I (2/2/98)
Text PDF
  • Medical Devices; Exemptions from Premarket Notification; Class II Devices (1/21/98)
Text PDF

Search the Releasable 510(k) database

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format :

Device Classification Name:
Regulation Number:
510(k) Number:
Device Name:
Applicant:
Contact:
Product Code:
Date Received:
Decision Date:
Decision:
Classification Advisory Committee:
Review Advisory Committee:
Summary or Statement

Summary/Statement/Purged Indicator:

Types:

Reviewed by Third Party (Y/N)
Expedited Review (Y/N)

Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered.

Listings are normally available about the 5th of each month for the prior month. Summaries are in pdf format and are available about 3 weeks after the monthly listing is posted. The 510(k) number is the indication of the link if the summary is available.

2004 Listings

September 2004 August 2004   July 2004
June 2004 May 2004   April 2004
March 2004 February 2004   January 2004

 

 

2003 Listings

December 2003 November 2003 October 2003
September 2003 August 2003 July 2003
June 2003 May 2003 April 2003
March 2003 February 2003 January 2003

2002 Listings

December 2002 November 2002 October 2002
September 2002 August 2002 July 2002
June 2002
May 2002
April 2002
March 2002
February 2002
January 2002

2001 Listings

December 2001 November 2001 October 2001
September 2001 August 2001 July 2001
June 2001 May 2001 April 2001
March 2001 February 2001 January 2001

2000 Listings

December 2000 November 2000 October 2000
September 2000 August 2000 July 2000
June 2000 May 2000 April 2000
March 2000 February 2000 January 2000

1999 Listings

December 1999 November 1999 October 1999
September 1999 August 1999 July 1999
June 1999 May 1999 April 1999
March 1999 February 1999 January 1999

Listings of CDRH Substantially Equivalent (SE) 510(k) Final Decisions for months prior to 1999 can be found using the 510(k) Final Decision search. The results of the search will be in a format similar to the current monthly listings.

Downloadable 510(k) Files

You can download any of the following zipped files, each of which contains information about the releasable 510(k)s for the time frame indicated. Information about how to unzip these files is available. Each record in the file is 272 characters in length. These files are replaced monthly usually on the 5th of each month. In addition there is a file description and an explanation of some of the codes used in the file. You can also download or search the Product Code Classification Database.

Most current month available PMNLSTMN.ZIP
1996-current PMN96CUR.ZIP
1991-1995 PMN9195.ZIP
1986-1990 PMN8690.ZIP
1981-1985 PMN8185.ZIP
1976-1980 PMN7680.ZIP

Back To Device Evaluation Page

Updated October 5, 2004

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