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

IQF · Predicate Candidate Screening

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

16 daysmedian FDA review time

36 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K832741	JASON CERVICAL ORTHOSIS	Orthomedics	1983-09-20	36
K812342	ZEE EXTRICATION DEVICE	Zee Medical Products Co., Inc.	1981-09-21	34
K811297	CERVICAL SUPPORT	Orthomedics	1981-05-27	16
K810555	SCOLIOSIS ORTHOTIC SYSTEM	Orthomedics	1981-03-13	11
K791350	POPE AMBULATORY HALO VEST	Hospital Products Co.	1979-08-03	17
K781761	KENDRICK EXTRICATION DEVICE	Medi-Ked, Inc.	1978-10-27	11
K780489	SPINE BOARD	Marullo, Baldwin, Frieden, Gatewood,	1978-04-12	16

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