# Heartstream, Inc.

- Location (FDA's records): Seattle, WA
- FDA decisions: 2 (1996–1997): 2 510(k) clearances
- Product codes: MKJ (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Defibtech, LLC: 2 (https://510kreport.com/company/defibtech)
- Physio-Control Corp.: 2 (https://510kreport.com/company/physio-control)
- Leonhard Lang GmbH: 1 (https://510kreport.com/company/leonhard-lang)
- Amco International Manufacturing & Design, Inc.: 1 (https://510kreport.com/company/amco-international-manufacturing-design)
- Survivalink Corp.: 1 (https://510kreport.com/company/survivalink)
- Aed Battery Exchange, LLC: 1 (https://510kreport.com/company/aed-battery-exchange)

## Its most-cited devices
- K955628: Fore Runner External Defibrillator/Defibrillator Pads (1996), cited by 7
- K972418: Heartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation Pads with Preattached Electrode Adapter (DP-Eaxx) (1997), cited by 1

## Recent decisions
- K972418: Heartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation Pads with Preattached Electrode Adapter (DP-Eaxx) (Sep 25, 1997)
- K955628: Fore Runner External Defibrillator/Defibrillator Pads (Sep 10, 1996)

Source page: https://510kreport.com/company/heartstream