510(k) Monitor

What is this? 510(k) Monitor is a companion to FDA FOIA Monitor, focused entirely on 510(k) premarket notifications, the single most requested and most requested-about device category in FDA's FOIA log. Each issue covers two things: what's newly available to request right now, and what the underlying FOIA data says about how 510(k) requests actually move through FDA.

50 New 510(k)s Now Available

We added 50 new 510(k) submission files to the document store this week, spanning devices cleared as far back as 1980 and as recently as 2025. A few worth calling out:

Two W. L. Gore vascular grafts, two orthopedic knee systems from Stryker and Zimmer, and a Medtronic defibrillator/monitor headline this batch, alongside a long tail of smaller devices going back to the 1980s.

Browse the full, searchable 510(k) Document Store for these and thousands of other already-available records.

510(k)s Are FOIA's Slowest Common Doc Type. Here's Why, and What's Changing.

Since 2020, FDA has closed 5,270 510(k) FOIA requests. Unlike Form 483 inspection reports, which close on an 18-to-22-day median across the whole dataset, 510(k) requests are one of the slowest categories FDA processes: a full premarket notification submission requires FDA to review and redact trade-secret and confidential commercial information line by line before release, and that review time dominates the timeline far more than search or duplication ever does.

Median days to close, by year of closure. Bar length proportional to days, scaled to 2020's 434-day high.

The trend: Median processing time has fallen every year since 2020, from 434 days to roughly 190-220 days, a genuine multi-year improvement even though 510(k)s remain far slower than doc types like 483s or correspondence requests. Within 2026, July was the fastest month yet at a 148-day median, down from January's 224 and March's 266.

Who files these requests matters, too. In 2026, Regulated Industry accounts for 45% of 510(k) closings, by far the largest share, which tracks with how the category is actually used: competitors requesting a rival's clearance file to understand what FDA accepted as a predicate device or safety argument. Individual/citizen filers are second at 34%, and law firms make up 13%, largely product-liability discovery. One commercial FOIA service, FOI Services Inc, alone accounts for 453 of the 5,270 closed 510(k) requests all-time (8.6%), more than five times the volume of the next-largest single requester.