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

GHR — Predicate Candidate Screening

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

84 daysmedian FDA review time

116 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K061991	PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA	Helena Laboratories	2007-02-23	225
K952252	ADP REAGENT, MODIFIED	Helena Laboratories	1995-09-08	116
K922800	PLATELET AGGREGATION REAGENTS	Chrono-Log Corp.	1992-08-26	77
K910800	ADP REAGENT	Helena Laboratories	1991-05-20	84
K910706	COLLAGEN REAGENT CAT. NO. 5368	Helena Laboratories	1991-05-20	89
K910680	EPINEPHRINE REAGENT, CAT. NO. 5367	Helena Laboratories	1991-05-20	94
K910286	PLATELET AGGREGATION REAGENTS	Medical Diagnostic Technologies, Inc.	1991-03-19	56
K900792	RISTOCETIN	Medical Diagnostic Technologies, Inc.	1990-03-27	35
K832428	PLATELET AGGREGATION REAGENT SET	Helena Laboratories	1983-10-20	90
K820422	PLATELET AGGREGOMETERS	Chrono-Log Corp.	1982-03-16	28
K760198	KIT, PLATELET AGGREGATION REAGENT (#390)	Chrono-Log Corp.	1976-07-19	13

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