510(k) · Cleared

Cleared

Heart Sync

K131494510(k) TraditionalCleared Sep 16, 2013116-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 Sep 16, 2013 as substantially equivalent to K082090 (Cardiac Science Corporation, 2008) after a 116-day review. Its family tree reaches back 3 generations to 1992.

Decided: Sep 16, 2013
Review: 116 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K914955 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK914955 K-Defib/Pace ElectrodeKatecho, Inc. · 1992
2 generations backK971149 SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 1997 · Recalled
1 generation backK082090 9131 Defibrillation ElectrodesCardiac Science Corporation · 2008
This deviceK131494 Heart SyncHeart Sync, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K914955	K-Defib/Pace Electrode	Katecho, Inc.	1992	—
−2	K971149	SVL-9130 Defibrillation Electrode	Survivalink Corp.	1997	1
−1	K082090	9131 Defibrillation Electrodes	Cardiac Science Corporation	2008	—
0 (this device)	K131494	Heart Sync	Heart Sync, Inc.	2013	—

FIG. 1 — Lineage of K131494, 1992–2013Source: 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.

Planning a device in MKJ? 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K082090	9131 Defibrillation Electrodes Summary page 1 …Common or usual name: Single Use Sterile Defibrillator Pad Classification name:fProduct Code MKJ. Class Ill (3) Predicate devices: 913 1 Defibrillation electrode. K082090, Cardiac Science Corporation (4) Description of the device: These are single use. jion-sterile, self-stick defibrillator electro…	Cardiac Science Corporation	2008	—

Also cleared against K082090: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K082090.

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. 2013, 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 tar use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T-Cardiac Science AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T-Cardiac Science AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131494: Heart Sync.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131494

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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