FDA Premarket Notification 510(k)

Source FDA

The FDA describes the Premarket Notification 510(k) Database in the following way:

"A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval."

A longer introduction to Premarket Notification 510(k) is also available.

The file layout describes the data fields.

The FDA offers many helpful, additional resources such as the following:

The complete FDA Premarket Notification database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

Updates and changes.

Time Period	Source Data File	Premarket Notification
Source	Stata	Stata 244	SAS	CSV	Desc
Most current month available	pmnlstmn.zip	txt	dta	dta	sas7bdat	csv	desc
1996-current	pmn96cur.zip	txt	dta	dta	sas7bdat	csv	desc
1991-1995	pmn9195.zip	txt	dta	dta	sas7bdat	csv	desc
1986-1990	pmn8690.zip	txt	dta	dta	sas7bdat	csv	desc
1981-1985	pmn8185.zip	txt	dta	dta	sas7bdat	csv	desc
1976-1980	pmn7680.zip	txt	dta	dta	sas7bdat	csv	desc