Atlas FDA

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

ILW · Predicate Candidate Screening

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

17 daysmedian FDA review time
47 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823632LONG HANDLED FOLDING HAIRBRUSHFred Sammons, Inc.1982-12-28220
K810457GROOMING ADAPTORSFred Sammons, Inc.1981-03-04130
K781197STICK, UTILITYFred Sammons, Inc.1978-07-31170
K781200NAIL CLIPPERS, ONE-HANDEDFred Sammons, Inc.1978-07-31170
K761123ELECTRIC RAZOR HOLDERFred Sammons, Inc.1976-12-02130
K760289BRUSH, DISPOSA-A (HANDLE, REFILL PKG)Fred Sammons, Inc.1976-09-08470
K760293MIRROR, EXTEND-A-, BK-6235Fred 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