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

KQC — Predicate Candidate Screening

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

37 daysmedian FDA review time

64 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K882873	FIELDTEX HEMATOXYLIN	Anatech, Ltd.	1988-07-28	17
K852843	GENERAL DIAGNOSTICS COAG-A-MATE XC	Warner-Lambert Co.	1985-08-13	39
K843619	RETIC-SET	R&D Systems, Inc.	1984-10-30	46
K841848	RETIC-SET	R&D Systems, Inc.	1984-05-31	64
K792550	PONCEAU S STAIN SET	Electrophoresis Corp. of America	1980-01-16	37
K792496	VOLU-SOL NMB RETICULOCYTE STAIN	Volu Sol Medical Industries	1979-12-31	27
K791007	STAT DIFF STAIN	Bioscientific	1979-08-03	64
K760485	HEMASTAIN FIXATIVE	Geometric Data, Div. Smithkline Corp.	1976-08-30	10
K760487	HEMASTAIN PHOSPHATE BUFFER	Geometric Data, Div. Smithkline Corp.	1976-08-30	10

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