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Information on Releasable 510(k)s |
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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)
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 |
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.
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 |
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Updated October 5, 2004
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