Heart Sync Pediatric Physio AED Pad

Q: What is the product code of K120536?

The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.

FDA 510(k) K120536 · Heart Sync, Inc.

Substantially Equivalent

510(k) numberK120536

Submission

Device name: Heart Sync Pediatric Physio AED Pad
Applicant: Heart Sync, Inc.
Naples, FL, US
Received: February 22, 2012
Decision date: August 6, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MKJ – Automated External Defibrillators (Non-Wearable)
Device class: Class III (high risk)
Regulation: 21 CFR 870.5310
Specialty: Cardiovascular

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…

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K150055	OneStep Pediatric CPR Multi-Function ElectrodeMKJ · Traditional	Bio-Detek, Inc.	05/02/2015SE
K142709	samaritan PAD 450PMKJ · Traditional	Heartsine Technologies, Inc.	03/27/2015SE
K133659	Heartstart Xl+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringMKJ · Traditional	Philips Medical Systems	01/23/2015SE
K133239	Zoll E SeriesMKJ · Traditional	Zoll Medical Corporation, World Wide Headquarters	01/16/2015SE
K142430	LIFEPAK 15 monitor/defibrillatorMKJ · Traditional	Physio-Control, Inc.	12/19/2014SE
K141795	Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional	R & D Batteries, Inc.	12/08/2014SE
K142915	ZOLL X SeriesMKJ · Traditional	ZOLL Medical Corporation	12/03/2014SE
K142803	Skintact, various other tradenamesMKJ · Traditional	Leonhard Lang GmbH	12/02/2014SE

More from Leonhard Lang GmbH

510(k)	Device	Decision
K131550	Heart SyncMKJ · Traditional	12/06/2013SE
K131494	Heart SyncMKJ · Traditional	09/16/2013SE
K081442	Heart Sync Pediatric, Model PED-100LDD · Traditional	09/24/2008SE
K080421	Heart Sync, Models C-100 and T-100MKJ · Traditional	02/29/2008SE

Questions and answers

When was Heart Sync Pediatric Physio AED Pad cleared by the FDA?

Heart Sync Pediatric Physio AED Pad (K120536) received a 510(k) decision of Substantially Equivalent on August 6, 2012, 166 days after the submission was received.

What is the product code of K120536?

The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.