Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

KID · Predicate Candidate Screening

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

42 daysmedian FDA review time
143 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963479WHEELCHAIR BELTDeroyal Industries, Inc.1997-01-241430
K963475PONCHO VEST RESTRAINTDeroyal Industries, Inc.1997-01-221410
K963480MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDERDeroyal Industries, Inc.1997-01-221410
K963459SUPPORT VESTSkil-Care Corp.1996-10-15420
K963461SAFETY PONCHO/SHOULDER STRAP PONCHOSkil-Care Corp.1996-10-11380
K963455SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROLSkil-Care Corp.1996-10-08350
K802603ECONO-FLOAT WHEELCHAIR FLOTATION CUSHIONJefferson Industries, Inc.1980-11-12220

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