510(k) Report

FDA applicant

Heart Sync, Inc.

Naples, FL5 decisions2008–201311 recalls

FDA records 5 decisions for Heart Sync, Inc. (Naples, FL) from 2008 to 2013: 5 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 8 predicates, 2 of them its own earlier devices. 11 recalls are linked to its devices, 5 Class I.

FDA’s records also spell it “Heart Sync, LLC”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Heart Sync, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2008: 22012: 12013: 2
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

5in 2014

2008: 22010: 22013: 22014: 5, 5 Class I
2008high 5 (2014) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Heart Sync, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)4decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 20084cite it
  • K081442Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 20082cite it

What has FDA decided for it lately?

  • K131550Heart SyncHeart Sync, Inc. · 2013
  • K131494Heart SyncHeart Sync, Inc. · 2013
  • K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012
  • K081442Heart Sync Pediatric, Model Ped-100Heart Sync, LLC · 2008
  • K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 20085 Class I recalls

All 3 as Heart Sync, Inc. →All 2 as Heart Sync, LLC →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K080421ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use…Nov 11, 2014Class I
  • K080421ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with…Nov 11, 2014Class I
  • K080421ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with…Nov 11, 2014Class I
  • K080421ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with…Nov 11, 2014Class I
  • K080421ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use…Nov 11, 2014Class I
  • K080421Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic…Apr 26, 2013Class II

Other applicant names beginning “Heart”

FDA records each applicant name separately; these may or may not be the same firm.

The Heart Valve Div. Medtronic Cardiovascular Surg 5Heart Technology, Inc. 4Heart Technology Mfg., Inc. 3Heart Imaging Technologies, LLC 2Heart Alert, Inc. 1Heart Sounds, Inc. 1Heart Rate, Inc. 1Heart Check Systems, Inc. 1Heart Rhythm Technologies, Inc. 1