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Fore Runner External Defibrillator/Defibrillator Pads

by Heartstream, Inc.

510(k) K955628

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955628 Date10 Sep 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MKJ
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ForeRunner External Defibrillator is an automated external defibrillator (non-wearable) designed to deliver electrical shocks to restore normal heart rhythm in victims of sudden cardiac arrest. It analyzes the victim’s ECG rhythm and, when a shockable rhythm is detected, delivers a minimum defibrillation shock of 130 Joules to defibrillate the heart.

This device is supplied as a reusable system with disposable defibrillator pads, intended for use in out-of-hospital and pre-hospital emergency settings. It is classified as a Class III medical device under FDA regulation 870.5310 and holds a 510(k) clearance (K955628) with a traditional review pathway. The device is not MRI-safe and must be stored in accordance with manufacturer guidelines to maintain functionality and sterility.

Other devices from Heartstream, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the ForeRunner External Defibrillator in emergency settings?

    The ForeRunner External Defibrillator is designed to restore normal heart rhythm in victims of sudden cardiac arrest by analyzing the victim’s ECG rhythm and delivering a minimum defibrillation shock of 130 Joules when a shockable rhythm is detected. It is specifically intended for use in out-of-hospital and pre-hospital emergency settings.

  • Is the ForeRunner External Defibrillator reusable, and if so, what components are disposable?

    Yes, the ForeRunner External Defibrillator itself is a reusable system. However, it is supplied with disposable defibrillator pads, which must be replaced for each use to ensure sterility and proper functionality.

  • How should the ForeRunner External Defibrillator be stored to maintain its functionality and sterility?

    The device must be stored according to the manufacturer’s guidelines to preserve its functionality and sterility. While the exact storage instructions are not detailed here, the manufacturer’s recommendations should be followed to ensure proper performance, especially since the device is not MRI-safe.

  • What regulatory pathway was used for the FDA clearance of the ForeRunner External Defibrillator?

    The ForeRunner External Defibrillator received FDA clearance through the 510(k) pathway with a traditional review process. It was classified as a Class III medical device under FDA regulation 870.5310 and holds clearance number K955628.