510(k) · Cleared

Cleared

Heart Sync Pediatric Physio Aed Pad

K120536510(k) TraditionalCleared Aug 6, 2012166-day reviewClass III21 CFR 870.5310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Heart Sync, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Aug 6, 2012 as substantially equivalent to K022732 (Medtronic Physio-Control Corp., 2002) and 2 other predicates after a 166-day review. Its family tree reaches back 3 generations to 2001. 3 of the 6 devices in its family, counting itself, have a Class I recall.

Decided: Aug 6, 2012
Review: 166 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K002280 (2001). 5 ancestors in all. No later device cites it as a predicate yet. 3 of the 6 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK002280 Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001 · Recalled (Class I)
2 generations backK020288 Padpro, Model 2603Padpro, LLC · 2002 · Recalled (Class I)
1 generation backK081442 Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008
This deviceK120536 Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012

Class I recalls in this family

K022732 Infant/Child Reduced Energy Electrodesdirect predicate · 2002
K020288 Padpro, Model 26032 generations back · 2002
K002280 Pad Pro Pediatric Electrode, Model Pad Pro 26023 generations back · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002280	Pad Pro Pediatric Electrode, Model Pad Pro 2602	Medical Devices, Inc.	2001	Class I
−2	K020288	Padpro, Model 2603	Padpro, LLC	2002	Class I
−1	K081442	Heart Sync Pediatric, Model Ped-100	Heart Sync, LLC	2008	—
0 (this device)	K120536	Heart Sync Pediatric Physio Aed Pad	Heart Sync, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	1

FIG. 1 — Lineage of K120536, 2001–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K022732	Infant/Child Reduced Energy Electrodes Summary page 1 …Defibrillator Pad for AED Classification name:/Product Code automated external defibrilIlators (non-wearable) Code MKJ. 21 CER 870.5310 (3) Predicate devices: K022732 Medtronic/Physio-Control Infant/Child Reduced Energy Electrodes; K003819, Defibrillator Electrodes/Pads PHILIPS - Forerunner…	Medtronic Physio-Control Corp.	2002	Class I
*	K003819	Heartstream Attenuated Defibrillation Pads, Model M3870A Summary page 1 …d external defibrilIlators (non-wearable) Code MKJ. 21 CER 870.5310 (3) Predicate devices: K022732 Medtronic/Physio-Control Infant/Child Reduced Energy Electrodes; K003819, Defibrillator Electrodes/Pads PHILIPS - Forerunner 2 Pediatric Defibrillator Pads, K081442 Heart Sync, HEART SYNC PEDIAT…	Agilent Technologies, Inc.	2001	4
*	K081442	Heart Sync Pediatric, Model Ped-100 Summary page 1 …K022732 Medtronic/Physio-Control Infant/Child Reduced Energy Electrodes; K003819, Defibrillator Electrodes/Pads PHILIPS - Forerunner 2 Pediatric Defibrillator Pads, K081442 Heart Sync, HEART SYNC PEDIATRIC, MODEL PED-100. (4) Description of the device: These are single use, non-sterile, self stic…	Heart Sync, LLC	2008	—

Also cleared against K022732: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
K020288Padpro, Model 2603Padpro, LLC · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K002280Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
4 of the 5 ancestors have a recall of any class; 3 have a Class I recall.
2 other devices also cite its predicate K022732.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MKJ

48in 2025

2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	69	12	3,958
2008	13	141	24	4,752
2009	8	165	37	6,782
2010	4	250	35	7,399
2011	11	36	7	8,170
2012	10	197	5 (1)	9,732
2013	7	191	4	14,955
2014	11	196	24 (15)	15,399
2015	6	156	1	16,129
2016	0	—	2 (1)	17,062
2017	4	—	6 (4)	16,684
2018	20	—	3	16,591
2019	25	—	6 (2)	16,861
2020	52	—	2	16,197
2021	41	—	4	16,300
2022	19	—	3	14,867
2023	24	—	11	13,766
2024	27	—	5	15,109
2025	48	—	1	13,315
2026	31	—	3	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120536 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120536: Heart Sync Pediatric Physio Aed Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120536

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026