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

KQW — Predicate Candidate Screening

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

43 daysmedian FDA review time

84 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K926237	O'BRIEN GONIOMETER	Sgarlato Laboratories, Inc.	1993-08-02	234
K901744	DOBBHOFF(R) RETRIEVAL FORCEPS	Biosearch Medical Products, Inc.	1990-07-03	77
K870767	THE (CROM) TESTER	Twin City Surgical, Inc.	1987-03-17	19
K850082	HAND HELD GONIOMETER	Chattanooga Group, Inc.	1985-04-04	84
K831550	FINGER BONIOMETER BK7506	Fred Sammons, Inc.	1983-06-24	43
K812778	THE TELOS EQUIPMENT	The Telos Co.	1981-12-08	64
K810441	UNIVERSAL GONIMETER	Fred Sammons, Inc.	1981-02-27	8
K801715	BK-7497 BULB DYNAMOMETER	Fred Sammons, Inc.	1980-08-04	11
K801716	BK-7505 RADIOPAQUE GONIOMETER, 8	Fred Sammons, Inc.	1980-08-04	11
K801717	BK-7511 BRASS GONIOMETER	Fred Sammons, Inc.	1980-08-04	11
K801718	BK-7513 STAINLESS STEEL GONIOMETER	Fred Sammons, Inc.	1980-08-04	11
K760301	GONIOMETER, MED. INTER. STAND. BK-7512	Fred Sammons, Inc.	1976-09-08	47
K760302	GONIOMETER, INTER. STAND. LARGE, BK7514	Fred Sammons, Inc.	1976-09-08	47

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