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

KQG — Predicate Candidate Screening

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

94 daysmedian FDA review time

213 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050821	COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM	Zycare	2005-08-16	138	0
K021976	FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON	Vital Scientific N.V.	2002-10-25	130	0
K992130	PACIFIC HEMOSTASIS THROMBOSCREEN 400C	Pacific Hemostasis	1999-09-03	72	0
K991321	PACIFIC HEMOSTASIS THROMBOSCREEN 200	Pacific Hemostasis	1999-06-21	63	0
K983475	HEMOCHRON RESPONSE	International Technidyne Corp.	1999-05-03	213	1
K902614	ELVI 828 DIGICLOT MULTISCAN	Logos Scientific, Inc.	1990-11-08	148	0
K900685	CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER	Texas Intl. Laboratories, Inc.	1990-04-16	63	0
K862047	COAGULATOR (8 CHANNEL)	Med USA	1986-09-29	123	0
K852492	COAGULATOR	Med USA	1985-08-13	62	0
K851169	ELECTRA 800 AUTOMATIC COAGULATION TIMER	Medical Laboratory Automation Systems, Inc.	1985-06-24	94	0
K823131	KOAGULAB 40-A AUTOMATED COAGULATION SYS	Ortho Diagnostic Systems, Inc.	1982-12-09	45	0
K812906	ELVI BICLOT 816	Volu Sol Medical Industries	1982-07-22	276	0
K791587	ELVI 810 CLOTSCANNER	Volu Sol Medical Industries	1979-09-17	31	0
K770914	INCUBATOR, PORTABLE, ACT-STAT	Thermolyne Corp.	1977-08-04	77	0

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