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

JMK · Predicate Candidate Screening

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

39 daysmedian FDA review time

354 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K983860	MTM BIOSCANNER K TEST STRIPS, CAT # BSA610	Polymer Technology Systems, Inc.	1999-12-27	420
K981865	MTM BIOSCANNER K TEST STRIPS	Polymer Technology Systems, Inc.	1999-02-26	274
K953452	KETOREX C SANWA	Ihara Medics U.S., Inc.	1996-05-02	289
K941427	SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)	Teco Diagnostics	1995-03-13	354
K862319	HBDH (OPTIMIZED) REAGENT	Sigma Chemical Co.	1986-07-07	19
K843774	RAICHEM X-HBDH REAGENT	Reagents Applications, Inc.	1984-10-31	36
K822739	AHBD	Gilford Diagnostics	1982-10-18	39
K821877	ULTRAZYME PLUS HBD	Harleco Diagnostics	1982-07-14	19
K781720	HBDH ENZYME KINETIC REAGENT SET	Medical Analysis Systems, Inc.	1978-11-03	23
K780104	ULTRAZYME PLUS HBD	Harleco	1978-02-13	24
K780073	HBDH REAGENT SET	Medical Analysis Systems, Inc.	1978-02-13	28
K780042	HYDORRYBUTYRATE DEHYDROGENASE	Beckman Instruments, Inc.	1978-02-01	23
K772033	GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*	Harleco	1977-11-17	21
K771474	MULTISTAT III X-HBDH TEST	Instrumentation Laboratory CO	1977-09-13	40
K770871	ULTRAZYME PLUS HBD	Harleco	1977-07-14	62
K760023	ULTRAZYME HBD	Harleco	1976-08-26	73

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