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

LJL — Predicate Candidate Screening

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

71 daysmedian FDA review time

375 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K151562	Resultz Lice & Egg Removal Kit	Piedmont Pharmaceuticals, LLC	2017-05-08	698
K163401	Nix Ultra Lice Treatment Kit	Medtech Products, Inc.	2017-03-21	106
K093144	LOUSEBUSTER	Larada Sciences	2009-12-16	72
K083206	LOUSEBUSTER	Larada Sciences	2009-03-10	130
K991958	KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT	Kiel Laboratories, Inc.	1999-08-13	64
K981147	CLEAR (TM) LICE EGG REMOVER SYSTEM	Care Technologies, Inc.	1998-06-09	71
K981250	LICEMEISTER COMB	National Pediculosis Assoc.	1998-05-28	52
K981037	CLEAR (TM) SPECIAL NIT COMB	Care Technologies, Inc.	1998-05-22	64
K930859	ROBI COMBI	Epilady 2000, LLC	1994-02-28	375
K822421	INNOCOMB LICE COMB	Innovative Products, Inc.	1982-10-13	58
K822574	INNOMED PD-1 KIT	Innomed Corp.	1982-10-13	50

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