# Heart Sync, Inc.

- Location (FDA's records): Naples, FL
- FDA decisions: 5 (2008–2013): 5 510(k) clearances
- Names in FDA's records: Heart Sync, Inc. (3); Heart Sync, LLC (2)
- Product codes: MKJ (4), LDD (1)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 11 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Padpro, LLC: 2 (https://510kreport.com/company/padpro)
- Cardiac Science Corporation: 1 (https://510kreport.com/company/cardiac-science)
- Katecho, Inc.: 1 (https://510kreport.com/company/katecho)
- Medtronic Physio-Control Corp.: 1 (https://510kreport.com/company/medtronic-physio-control)
- Agilent Technologies, Inc.: 1 (https://510kreport.com/company/agilent-technologies)

## Firms that cite its devices most
- Cardio Medical Products, Inc.: 2 (https://510kreport.com/company/cardio-medical-products)
- Fiab Spa: 2 (https://510kreport.com/company/fiab)

## Its most-cited devices
- K080421: Heart Sync, Models C-100 and T-100 (2008), cited by 4
- K081442: Heart Sync Pediatric, Model Ped-100 (2008), cited by 2

## Recent decisions
- K131550: Heart Sync (Dec 6, 2013)
- K131494: Heart Sync (Sep 16, 2013)
- K120536: Heart Sync Pediatric Physio Aed Pad (Aug 6, 2012)
- K081442: Heart Sync Pediatric, Model Ped-100 (Sep 24, 2008)
- K080421: Heart Sync, Models C-100 and T-100 (Feb 29, 2008)

Source page: https://510kreport.com/company/heart-sync