Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

IOD — Predicate Candidate Screening

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

18 daysmedian FDA review time

43 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K831544	DELUXE TRACTION EXERCISE GLOVE BK5035	Fred Sammons, Inc.	1983-06-24	43
K823648	SURGICAL TUBING	Fred Sammons, Inc.	1983-01-21	46
K823822	ANKLE WEIGHTS	Danek Medical, Inc.	1983-01-14	28
K823600	SOLID WOOD CONE	Fred Sammons, Inc.	1982-12-22	16
K813632	COLOR CODED WEIGHT CUFFS	Fred Sammons, Inc.	1982-01-19	21
K812319	THERAPY BENCH	Kaye Products, Inc.	1981-08-31	14
K790587	CANVAS WEDGE	Maddak, Inc.	1979-04-03	7
K772414	SANDBAGS, VARIOUS WEIGHTS	Fred Sammons, Inc.	1978-02-01	36
K771030	FLEXION MITTENS	Stat Medical Corp.	1977-06-27	18
K761118	HAND SCREW CLAMP	Fred Sammons, Inc.	1976-12-02	13
K761119	SHEET METAL CLAMP	Fred Sammons, Inc.	1976-12-02	13

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