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

LBT — Predicate Candidate Screening

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

70 daysmedian FDA review time

164 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K000568	HDL CHOLESTEROL PLUS	Roche Diagnostics Corp.	2000-08-04	164
K990250	HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/H	Morax	1999-06-18	143
K972015	HYDRAGEL 7,15,30, CHOL-HDL KIT	Morax	1997-10-27	150
K904035	REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM	Helena Laboratories	1990-11-09	70
K894366	REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187	Helena Laboratories	1989-08-31	48
K882368	REP HDL ELECTROPHORESIS METHOD	Helena Laboratories	1988-08-08	61
K873547	TITAN GEL HDL CHOLESTEROL KIT	Helena Laboratories	1987-10-02	31
K790791	ELECTROPHORESIS REAGENT SET, HDL	Gelman Sciences, Inc.	1979-06-15	52

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