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

CGE — Predicate Candidate Screening

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

34 daysmedian FDA review time

77 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K890335	SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.	Alpkem Corp.	1989-02-17	25
K855185	GLUCOSE REAGENT SET	Technostics Intl.	1986-01-22	27
K850930	GLUCOSE	Dilab, Inc.	1985-06-10	95
K841054	DIRECT GLUCOSE REAGENT SET	Medical Specialties, Inc.	1984-05-01	50
K821198	DIRECT GLUCOSE REAGENT SET	Omega Medical Electronics	1982-07-13	77
K811883	KING DIAGNOSTICS GLUCOSE-O TEST	King Diagnostics, Inc.	1981-07-23	22
K810089	6% ORTHO LOLIUDINE REAGENT IN GLACID ACI	Anco Medical Reagents & Assoc.	1981-01-26	13
K790319	ORTHO-TOLUIDINE REAGENT SET	Fisher Scientific Co., LLC	1979-03-21	34
K781308	GLUCOLOUR	Analytical & Research Chemicals, Inc.	1978-08-31	34
K771314	GLUCOSE REAGENT (O-TOLUIDINE)	Mallinckrodt Critical Care	1977-08-03	16
K771091	UNIPAK GLUCOSE	Harleco	1977-07-21	35
K770455	GLUCOSE PROCEDURE, TEKPOINT DIRECT	Icn Pharmaceuticals, Inc.	1977-05-03	56

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