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

JBX — Predicate Candidate Screening

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

68 daysmedian FDA review time

93 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K932566	AGGRO/LINK CONTROL SOFTWARE	Chrono-Log Corp.	1993-11-02	159
K912774	ARACHIDONIC ACID	Helena Laboratories	1991-08-22	59
K881829	PAT PLATELET AGGREGATION TEST	Streck Laboratories, Inc.	1988-07-01	63
K862775	ASSERACHROM B-TG KIT	American Bioproducts Co.	1986-10-22	92
K851025	AGGRO/LINK COMPUTER INTERFACE	Chrono-Log Corp.	1985-06-12	93
K850592	PLATELET AGGREGATION REAGENT	Chrono-Log Corp.	1985-05-13	87
K832929	RISTOCETIN PLATELET AGGREGA-REAGENT TEST	Sigma Chemical Co.	1983-09-29	36
K830749	PLATELET AGGREGOMETER	Chrono-Log Corp.	1983-05-16	68
K821005	PLATELET AGGREGATION PROFILER #PAP-4	Bio/Data Corp.	1982-06-01	50
K811290	ARACHIDONIC ACID	Bio/Data Corp.	1981-07-27	77
K781710	BUFFER, COLLAGEN REAGENT AND DILUENT	Diagnostica, Inc.	1978-10-24	19
K760159	AGGREGOMETER, DUAL CHANNEL PLATELET	Chrono-Log Corp.	1976-07-20	18

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