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

Cholestech Corp. — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

112 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040579	CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)	Cholestech Corp.	2004-06-18	106	2
K032027	CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)	Cholestech Corp.	2003-09-05	66	1
K991834	CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772	Cholestech Corp.	1999-09-09	104	1
K972012	CHOLESTECH BUN/CREATININE TEST SYSTEM	Cholestech Corp.	1997-07-24	55	0
K954778	CHOLESTECH LDX SYSTEM	Cholestech Corp.	1995-11-24	66	0
K946066	TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL	Cholestech Corp.	1995-02-22	99	0
K946065	TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL	Cholestech Corp.	1995-02-22	99	0
K946063	TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL	Cholestech Corp.	1995-02-22	99	0
K946067	TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOS	Cholestech Corp.	1995-02-22	99	0
K946064	TOTAL CHOLESTEROL CASSETTE	Cholestech Corp.	1995-02-22	99	0
K932727	CHOLESTECH L.D.X. SYSTEM	Cholestech Corp.	1993-11-09	158	0
K922612	CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE	Cholestech Corp.	1992-06-24	22	0
K914469	CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL	Cholestech Corp.	1991-10-30	23	0
K914033	CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST	Cholestech Corp.	1991-09-27	17	0
K912136	CHOLESTECH LIPID MONITORING SYS.	Cholestech Corp.	1991-07-30	77	0
K911578	CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION	Cholestech Corp.	1991-05-15	49	0
K904082	CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST	Cholestech Corp.	1990-12-26	112	1
K905296	CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL	Cholestech Corp.	1990-12-26	29	0
K904784	CHOLESTECH L.D.X. LEVEL 1 CONTROL	Cholestech Corp.	1990-12-18	57	0
K901900	L.D.X LIPID MONITORING SYSTEM	Cholestech Corp.	1990-07-24	88	1

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