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

CGO — Predicate Candidate Screening

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

35 daysmedian FDA review time

63 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K850938	CHOLESTEROL	Dilab, Inc.	1985-06-25	110
K811747	KING DIAGNOSTICS CHOLESTEROL TEST	King Diagnostics, Inc.	1981-07-10	18
K810090	CHOLESTEROL REAGENT	Anco Medical Reagents & Assoc.	1981-01-26	13
K800682	REAGENTS FOR DETERM. CHOLESTEROL/SERUM	Diagnostic Solutions, Inc.	1980-05-28	63
K781611	CHOLESTEROL DET. IN SERUM	Fisher Scientific Co., LLC	1978-10-24	35
K780545	SR-PLUS DIRECT CHOLESTEROL TEST	Stanbio Laboratory	1978-05-26	53
K772043	ALPHA/CHOL	Standard Scientific, Inc.	1977-11-28	31
K771833	CHOLESTEROL	Gamma Enterprises, Inc.	1977-10-18	27
K771313	CHOLESTEROL REAGENT	Mallinckrodt Critical Care	1977-08-03	16
K771093	UNIPAK CHOLESTEROL	Harleco	1977-07-21	35
K770457	CHOLESTEROL PROCEDURE, TEKPOINT TOTAL	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