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

JHW — Predicate Candidate Screening

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

50 daysmedian FDA review time

173 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162526	Creatine Kinase-MB	Roche Diagnostics	2017-05-26	259	0
K141265	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT	Elitechgroup	2014-07-18	64	0
K122083	ELITECH CLINICAL SYSTEMS CK NAC SL	Elitechgroup	2012-08-22	37	0
K023744	WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR.	Wiener Laboratories Saic	2003-01-03	57	0
K003158	ROCHE DIAGNOSTICS CK-MB	Roche Diagnostics Corp.	2000-12-18	69	0
K961501	ELECSYS CK-MB	Boehringer Mannheim Corp.	1996-06-11	54	0
K950186	CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO D	Miles, Inc.	1995-03-13	55	0
K944325	LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN	Princeton BioMeditech Corp.	1995-02-22	173	0
K942958	CREATINE KINASE MB DETERMINATION (UV)	Biochemical Trade, Inc.	1994-11-21	151	1
K935924	AXSYM CK-MB	Abbott Laboratories	1994-06-21	190	0
K931050	CARDIO REP CK ISOENZYME KIT - 3310	Helena Laboratories	1993-04-20	50	0
K913349	STAMBI-CK	Intl. Immunoassay Laboratories, Inc.	1991-10-23	89	0
K912231	PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT	Intl. Immunoassay Laboratories, Inc.	1991-07-08	49	0
K905588	CREATINE KINASE UV REAGENT SET	Biochemical Trade, Inc.	1991-01-17	35	0
K903508	LABELLING CHANGES TO IMPRES-MB-X	Intl. Immunoassay Laboratories, Inc.	1990-09-07	38	0
K883222	ISOFOR-MM (TM)	Intl. Immunoassay Laboratories, Inc.	1988-09-30	63	0
K881801	IMPRES-MB	Intl. Immunoassay Laboratories, Inc.	1988-06-08	42	0
K822897	DSL 1700	Diagnostic Systems Laboratories, Inc.	1982-12-15	78	0
K811573	CARDIOZYME PLUS CK-MB ITEM #65045	Harleco	1981-06-25	21	0
K811575	CARDIOZYME PLUS CK-MB ITEM #65045 (G)	Harleco	1981-06-25	21	0
K810861	CREATINE KINASE MB ISOENZYME IMMUNO UV	The Dow Chemical Co.	1981-04-14	14	0
K810905	ISOMUNE-CK	Hoffmann-La Roche, Inc.	1981-04-14	11	0
K803168	CARDIO ZYME PLUS CK-MB #65045	Harleco	1981-01-09	25	0
K792533	CREATINE PHOSPHOKINASE (CPK) REAGENT SET	Macomb Chemical Co.	1980-01-11	35	0
K782015	A-GENT CK-MB	Abbott Laboratories	1979-02-01	58	0
K781124	CPK ISOENZYME REAGENT	Electrophoresis Corp. of America	1978-08-10	38	0
K772172	DYNAZYME TM II CARDIAK-MB	J.T. Baker Chemical Co.	1977-12-06	15	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