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

JHT — Predicate Candidate Screening

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

52 daysmedian FDA review time

114 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K022409	SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST	Spectral Diagnostics, Inc.	2002-09-30	68
K991299	MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STE	Princeton BioMeditech Corp.	1999-05-28	52
K930359	CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305	Helena Laboratories	1993-04-12	76
K904866	COULTER CK-MB ISOENZYME REAGENT	Coulter Electronics, Inc.	1990-12-13	45
K904721	DSL CK-MB (DSL #3200)	Diagnostic Systems Laboratories, Inc.	1990-12-13	56
K901450	MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB	Intl. Immunoassay Laboratories, Inc.	1990-05-15	48
K896170	REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083	Helena Laboratories	1990-02-16	114
K881168	CREATINE KINASE (CK) ISOENZYME MB	Data Medical Associates, Inc.	1988-11-10	237
K874284	SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM	Diagnostic Chemicals, Ltd. (Usa)	1988-01-21	99
K872041	COULTER DART CK-MB ISOENZYME REAGENT SYSTEM	Coulter Electronics, Inc.	1987-09-16	112
K872598	MICROMI-CK(TM)	Intl. Immunoassay Laboratories, Inc.	1987-08-03	32
K872592	IMACK-MB(TM)	Intl. Immunoassay Laboratories, Inc.	1987-07-31	30
K831391	SHOT GUN KIT FOR CK-MB	Serapine Corp.	1983-11-04	189
K823550	CK-ISOZYME U.V. REAGENT SET	Gelman Sciences, Inc.	1983-01-07	38
K822124	TITAN GEL CPK ISOENZYME SYSTEM	Helena Laboratories	1982-11-01	105
K821964	125I QUICK-MB TEST KIT FOR QUANTITATION	Intl. Immunoassay Laboratories, Inc.	1982-07-22	21
K810534	GEMENI QUICK-MB SEPARATION KIT	Gemini, Inc.	1981-03-11	13
K791826	CPK CLINI GEL KIT	Clinical Sciences, Inc.	1979-10-01	14
K790357	CPK-CS	Hoffmann-La Roche, Inc.	1979-04-04	40
K771497	CK-MB	Boehringer Mannheim Corp.	1977-08-22	17
K760028	CPK - ISOENZYMES	Harleco	1976-09-15	93

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