Atlas FDA

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

ILD — Predicate Candidate Screening

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

21 daysmedian FDA review time
27 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K831539ECONOMY PLASTIC SOCK-BK2084-AIDFred Sammons, Inc.1983-06-08270
K823604ROD W/HOOK TO PULL CLOTHES ONFred Sammons, Inc.1982-12-28220
K823603FORMED PLASTIC PANTY HOSE AIDFred Sammons, Inc.1982-12-28220
K823628LEATHER & VELCRO SHOE FASTENERFred Sammons, Inc.1982-12-28220
K823627LEATHER I VELCRO SHOE FASTENER REPAIRFred Sammons, Inc.1982-12-28220
K823602REGULAR SHOE HORN W/CYLINDRICAL HANDLEFred Sammons, Inc.1982-12-22160
K821858NOTIE STRETCH-LACE-VARIOUS MODELSFred Sammons, Inc.1982-07-0290
K821856BK-2082 FOLDING STOCKING AIDFred Sammons, Inc.1982-07-0290
K821859ORTHOLACE 4,5.6 EYELETFred Sammons, Inc.1982-07-0290
K813634ONE HANDED SHOE FASTENERFred Sammons, Inc.1982-01-19210
K811492DRESSING ADAPTORSFred Sammons, Inc.1981-06-12170
K810453DRESSING ADAPTORSFred Sammons, Inc.1981-03-04130
K790171BK-2084 PLASTIC SOCK AND STOCKING AIDFred Sammons, Inc.1979-02-08130
K760287BUTTON AID W/POCKET CLIP, BK-2011Fred Sammons, Inc.1976-09-08470

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