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

KNP — Predicate Candidate Screening

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

24 daysmedian FDA review time

46 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K831690	IPOS ANTI-ADDUCTUS SHOE	Ipos Luneburg	1983-06-24	31
K831552	SORBOTHANE VISCO INNER SOLE PAD	Fred Sammons, Inc.	1983-06-08	27
K823654	SLIP-ON SANDALS FOR MEASURING SHORTNESS	Fred Sammons, Inc.	1983-01-21	46
K823665	ROTATION BOOT	Warm & Form, Orthopedic Materials	1982-12-30	24
K810228	SORBOTHANE	Hamilton Kent	1981-02-10	14
K801743	PLASTAZOTE SHOE	Alimed, Inc.	1980-08-07	10
K790326	DRUSHOE	J.E. Hanger & Co. , Ltd.	1979-02-26	11

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