|
||
|
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.
2008 Listings
August 2008 | July 2008 | |
June 2008 | May 2008 | April 2008 |
March 2008 | February 2008 | January 2008 |
2007 Listings
December 2007 | November 2007 | October 2007 |
September 2007 | August 2007 | July 2007 |
June 2007 | May 2007 | April 2007 |
March 2007 | February 2007 | January 2007 |
2006 Listings
December 2006 | November 2006 | October 2006 |
September 2006 | August 2006 | July 2006 |
June 2006 | May 2006 | April 2006 |
March 2006 | February 2006 | January 2006 |
2005 Listings
December 2005 | November 2005 | October 2005 |
September 2005 | August 2005 | July 2005 |
June 2005 | May 2005 | April 2005 |
March 2005 | February 2005 | January 2005 |
2004 Listings
December 2004 | November 2004 | October 2004 |
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 510(k) Final Decisions. 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 |
Back To Device Evaluation Page
Updated September 5, 2008
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH