Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FWB · Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

39 daysmedian FDA review time
137 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934092CAMERA, SURGICAL AND ACCESSORIESEnvision Medical Corp.1994-01-071370
K902359SURGICAL VIDEO CAMERA, MODEL 9500Seitz Technical Products, Inc.1990-07-12440
K884343SONY COLOR VIDEO CAMERAS AND ACCESSORIESSony Corp. of America1988-11-01180
K871057MC-SERIES SURGICAL CAMERASM.P. Video, Inc.1987-04-03170
K855020MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930Medline Industries, Inc.1986-01-24390
K820829MEDICAMM.P. Video, Inc.1982-05-03390

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda