Product Code: LIX FDA class 2 21 CFR 870.5210

Aid, Cardiopulmonary Resuscitation

Cardiovascular

A cardiopulmonary resuscitation (CPR) aid device with software-driven feedback provides real-time audio and/or visual feedback on one or more CPR performance parameters such as compression rate, depth, and ventilation ratio, assisting rescuers in delivering effective CPR during cardiac arrest. As defined by the FDA, this device incorporates software and delivers real-time performance guidance. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIX and is regulated under 21 CFR 870.5210 within the Cardiovascular specialty. No special flags apply to this device.

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Basic Information

Product Code: LIX
Device Class: FDA class 2
Regulation Number: 870.5210
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201581	CPR BAND	Mar 06, 2021	Substantially Equivalent	Credo
K183348	Reusable Silicone Cover CPRmeter 2	Dec 17, 2018	Substantially Equivalent	Laerdal Medical AS
K173886	CPRmeter 2 CPR Feedback Device	Mar 23, 2018	Substantially Equivalent	Laerdal Medical AS
K151702	Reusable Full Silicone Cover	Aug 13, 2015	Substantially Equivalent	Laerdal Medical AS
K123248	CPR RSQ ASSIST	Dec 10, 2013	Substantially Equivalent	Avantech, Inc.
K123597	TRUECPR COACHING DEVICE	Apr 17, 2013	Substantially Equivalent	Physio-Control, Inc.
K122050	CPRMETER CPR FEEDBACK DEVICE	Oct 22, 2012	Substantially Equivalent	Laerdal Medical A/S
K112660	POCKETCPR	May 10, 2012	Substantially Equivalent	Zoll Medical Corp
K092408	RHYTHM OF LIFE, MODEL R0901-05	Oct 14, 2009	Substantially Equivalent	Rapid Response Solutions, LLC
K071321	POCKETCPR	Sep 12, 2007	Substantially Equivalent	Bio-Detek, Inc.
K010526	MODIFICATION TO THE GRIP	Dec 13, 2001	Substantially Equivalent	Elcare Innovations, Inc.
K003937	CPR EZY MASK AND PAD	Jun 06, 2001	Substantially Equivalent	Medteq Innovations Pty, Ltd.
K954692	CPR PROMPT	Mar 27, 1996	Substantially Equivalent	County Line , Ltd.
K926333	CPR PLUS	Nov 08, 1993	Substantially Equivalent	Kells Medical, Inc.
K900415	C.P.R. LANDMARC	Jun 12, 1990	Substantially Equivalent	Can-Am Medical, Inc.
K843977	PULSE-AID DEVICE	Feb 01, 1985	Substantially Equivalent	James J. Lally
K833737	CPR LOCATOR	Aug 24, 1984	Substantially Equivalent	Lifepoint,Inc