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

ITQ — Predicate Candidate Screening

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

16 daysmedian FDA review time

24 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K831044	LIMITED MOTION FUNCTIONAL KNEE BRACE	Orthopedic Systems, Inc.	1983-06-24	85
K831310	BRACE C.T.	Innovation Sports, Inc.	1983-05-16	24
K823658	DELUXE KNEE IMMOBILIZER(UNIVERSAL)	Warm & Form, Orthopedic Materials	1982-12-30	24
K823397	ANATOMIC FRACTURE BRACE	Orthopedic Systems, Inc.	1982-11-29	17
K823159	DELUXE KNEE IMMOBILIZER	Warm & Form, Orthopedic Materials	1982-11-10	16
K812423	NEOPRENE KNEE SUPPORT	Surgical Appliance Industries, Inc.	1981-09-14	21
K812094	AIRCAST PNEUMATIC KNEE BRACE	Aircast, Inc.	1981-08-13	20
K811689	CYLINDER KNEE CAST/SPLINT	Surgical Appliance Industries, Inc.	1981-06-25	10
K810222	LIMB ORHTOSIS	Medical Design & Manufacturing Corp.	1981-02-04	8
K802673	KNEE BRACE/STABILIZER	Omni Scientific, Inc.	1980-11-12	16
K780892	FRACTURE BRACING	Hosmer Dorrance Corp.	1978-06-13	13
K772268	DEMI-WALKER (REGULAR)	Med Fusion Systems, Inc.	1977-12-20	11
K772270	SETUP WALKER OVER TOILET CONSTRUC.	Med Fusion Systems, Inc.	1977-12-20	11
K772269	SETUP WALKER ADJUSTABLE	Med Fusion Systems, Inc.	1977-12-20	11
K772271	WALKER FOLDING ADJUSTABLE	Med Fusion Systems, Inc.	1977-12-20	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