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

LIX — Predicate Candidate Screening

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

147 daysmedian FDA review time

327 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K201581	CPR BAND	Credo	2021-03-06	268
K183348	Reusable Silicone Cover CPRmeter 2	Laerdal Medical AS	2018-12-17	14
K173886	CPRmeter 2 CPR Feedback Device	Laerdal Medical AS	2018-03-23	92
K151702	Reusable Full Silicone Cover	Laerdal Medical AS	2015-08-13	50
K123248	CPR RSQ ASSIST	Avantech, Inc.	2013-12-10	419
K123597	TRUECPR COACHING DEVICE	Physio-Control, Inc.	2013-04-17	147
K122050	CPRMETER CPR FEEDBACK DEVICE	Laerdal Medical A/S	2012-10-22	102
K112660	POCKETCPR	Zoll Medical Corp	2012-05-10	240
K092408	RHYTHM OF LIFE, MODEL R0901-05	Rapid Response Solutions, LLC	2009-10-14	69
K071321	POCKETCPR	Bio-Detek, Inc.	2007-09-12	125
K010526	MODIFICATION TO THE GRIP	Elcare Innovations, Inc.	2001-12-13	294
K003937	CPR EZY MASK AND PAD	Medteq Innovations Pty, Ltd.	2001-06-06	168
K954692	CPR PROMPT	County Line , Ltd.	1996-03-27	168
K926333	CPR PLUS	Kells Medical, Inc.	1993-11-08	327
K900415	C.P.R. LANDMARC	Can-Am Medical, Inc.	1990-06-12	133
K843977	PULSE-AID DEVICE	James J. Lally	1985-02-01	119
K833737	CPR LOCATOR	Lifepoint,Inc	1984-08-24	304

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