Atlas FDA

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

ILT · Predicate Candidate Screening

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

46 daysmedian FDA review time
47 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823656SOFT CATCHER'S MITTFred Sammons, Inc.1983-01-21460
K823657CARD HOLDER FOR QUADSFred Sammons, Inc.1983-01-21460
K781199HOLDER, CARD, QUAD-QUIPFred Sammons, Inc.1978-07-31170
K761116BREATH CONTROL GAMEFred Sammons, Inc.1976-12-02130
K760288VIEWER, RECLINING, BK-4089Fred Sammons, Inc.1976-09-08470
K760291HOLDER, PENCIL & CRAYON, WITH STANDFred Sammons, Inc.1976-09-08470
K760306CARDS, GIANT FACE PLAYING BK-9419Fred 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