510(k) · Cleared

Cleared

Heart Sync

K131550510(k) TraditionalCleared Dec 6, 2013191-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 Dec 6, 2013 as substantially equivalent to K080421 (Heart Sync, LLC, 2008) after a 191-day review. Its family tree reaches back 3 generations to 1998. 2 of the 4 devices in its family, counting itself, have a Class I recall.

Decided: Dec 6, 2013
Review: 191 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K981737 (1998). No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK981737 K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 1998
2 generations backK020203 Padpro Model #2516Padpro, LLC · 2002 · Recalled (Class I)
1 generation backK080421 Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Recalled (Class I)
This deviceK131550 Heart SyncHeart Sync, Inc. · 2013

Class I recalls in this family

K080421 Heart Sync, Models C-100 and T-100direct predicate · 2008
K020203 Padpro Model #25162 generations back · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K981737	K-Defib/Pace Adult Electrode Model Number KDP-60	Katecho, Inc.	1998	—
−2	K020203	Padpro Model #2516	Padpro, LLC	2002	Class I
−1	K080421	Heart Sync, Models C-100 and T-100	Heart Sync, LLC	2008	Class I
0 (this device)	K131550	Heart Sync	Heart Sync, Inc.	2013	—

FIG. 1 — Lineage of K131550, 1998–2013Source: 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.

2 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

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
*	K080421	Heart Sync, Models C-100 and T-100 Summary page 1 …CIOO-ZOLL. Common or usual name: Single Use Sterile Defibrillator Pad Classification name:/Product Code MKJ/MLN, Class Ill (3) Predicate devices: Identical to K080421, Heart Sync C-I00/T-l00 in materials and construction, except now available sterile. (4) Description of the device: These ar…	Heart Sync, LLC	2008	Class I

Also cleared against K080421: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 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.

K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
K020203Padpro Model #2516Padpro, LLC · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
3 other devices also cite its predicate K080421.

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?

Read the full statement (114 words)

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous; (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Physio Control, Zoll, and 'Anderson" adapted models of monophasic and bi-phasic defibrillators.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131550 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131550: 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/K131550

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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