# K120536: Heart Sync Pediatric Physio Aed Pad

- Pathway: 510(k) (Traditional)
- Applicant: Heart Sync, Inc.
- Decided: Aug 6, 2012 after 166 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002280 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022732: Infant/Child Reduced Energy Electrodes, Medtronic Physio-Control Corp. (2002) Summary page 1.
- K003819: Heartstream Attenuated Defibrillation Pads, Model M3870A, Agilent Technologies, Inc. (2001) Summary page 1.
- K081442: Heart Sync Pediatric, Model Ped-100, Heart Sync, LLC (2008) Summary page 1.

## Indications for use
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

Source page: https://510kreport.com/device/K120536
Methodology: https://510kreport.com/methodology