Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GGW — Predicate Candidate Screening

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

84 daysmedian FDA review time

245 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260551	HemosIL Factor V Leiden (APC Resistance V)	Instrumentation Laboratory (IL) Co.	2026-03-20	30	0
K090105	LUPOTEK KCT	R2 Diagnostics, Inc.	2010-12-30	714	0
K083729	HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL	Aniara Diagnostica, LLC	2009-05-08	143	0
K060284	CRYOCHECK CLOT APCR	Precision Biologic, Inc.	2006-05-10	96	0
K042762	PEFAKIT APC-R FACTOR V LEIDEN	Pentapharm , Ltd.	2004-12-22	78	0
K033471	PHOSPHOLIN ES AND CALCIUM CHLORIDE	R2 Diagnostics, Inc.	2004-02-04	93	0
K992456	GRADILEIDEN V TEST	Gradipore , Ltd.	1999-12-21	151	0
K982062	CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10	Precision Biologicals, Inc.	1999-01-13	212	0
K963111	COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V	Chromogenix AB	1996-12-23	133	0
K945940	COATEST(R) APC(TM) RESISTANCE	Axis-Shield Doc AS	1995-08-07	245	0
K941210	PTT-LT TEST KIT	American Bioproducts Co.	1995-03-21	372	0
K924370	STACLOT(R) PNP TEST KIT	American Bioproducts Co.	1993-08-09	346	0
K921684	PTT-LA TEST KIT	American Bioproducts Co.	1992-06-09	62	1
K915463	ACTIVATED PARTIAL THROMBOPLASTIN TIME	Sigma Diagnostics, Inc.	1992-01-23	50	0
K902236	READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT	Biosearch Medical Products, Inc.	1990-08-14	89	0
K873382	PLATELET EXTRACT REAGENT	Bio/Data Corp.	1987-11-20	88	0
K863594	ACTIN FSL ACTIVATED PTT REAGENT	American Dade	1986-10-17	32	2
K861190	PTT AUTOMATE TEST KIT	American Bioproducts Co.	1986-06-23	84	0
K853897	CITREX H	Bio/Data Corp.	1985-10-10	20	0
K852195	CEPHALINEX ACTIVATED PTT REAGENT	Bio/Data Corp.	1985-08-12	84	0
K851126	ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC	E.I. Dupont DE Nemours & Co., Inc.	1985-05-29	71	0
K841522	CALCIUM CHLORIDE	Diatech, Inc.	1984-04-30	18	0
K830320	ACTIVAT-PARTIAL THROMBO-PLASTIN	Helena Laboratories	1983-04-05	64	0
K822782	ACUSCREEN	Ortho Diagnostic Systems, Inc.	1982-10-08	24	0
K811589	ACTIN FS ACTIVATED PTT REAGENT	American Dade	1981-07-16	38	1
K802232	AB-TROL COAGULATION CONTROL	Helena Laboratories	1980-11-12	58	0
K801932	HEP-TROL	Helena Laboratories	1980-09-09	28	0
K801460	PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT	Pacific Hemostasis	1980-07-28	34	0
K800925	VERIFY S PROD. #34141	General Diagnostics	1980-07-21	91	0
K800787	ANTIBODY TO VARICELLA-ZOSTER VIRUS	Electro-Nucleonics Laboratories, Inc.	1980-07-14	97	0
K800725	A-GENT QUANTICHROM THROMBIGEN I	Abbott Laboratories	1980-06-04	64	0
K792048	LANCER COAGENT APTT KIT	Sherwood Medical Co.	1979-11-05	24	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