Heartstart 1000S

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

510(k) Number

K883344 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modified Heartstart Defibrillation Electrode

  Class II

  FDA 510(k) K902429 Active Cleared 27 Sep 1990

• Heartstart 2000 Defibrillation Electrode

  Class II

  FDA 510(k) K885186 Active Cleared 23 Feb 1989

• Heartstart 1000

  Class III

  FDA 510(k) K883341 Active Cleared 12 Sep 1988

• Modified Heartstart 2000 Defibrillation Electrode

  Class II

  FDA 510(k) K900169 Active Cleared 26 Jan 1990

• Is the Heartstart 1000S suitable for use by untrained responders, and how does it guide them during an emergency?

  Yes, the Heartstart 1000S is designed specifically for untrained responders. It provides both voice prompts and visual guidance to assist users in performing cardiopulmonary resuscitation (CPR) and delivering defibrillation shocks to restore a normal heart rhythm during sudden cardiac arrest. This makes it ideal for pre-hospital and public access programs where trained medical personnel may not be immediately available.

• What type of environment is the Heartstart 1000S intended for, and can it be used in both emergency and clinical settings?

  The Heartstart 1000S is intended for use in a variety of environments, including pre-hospital settings (such as emergency medical services), public access programs, and in-hospital clinical environments. Its design ensures versatility for both emergency responders and healthcare professionals who may encounter sudden cardiac arrest.

• How is the Heartstart 1000S supplied, and does it require any special storage conditions?

  The Heartstart 1000S is supplied as a single-use, non-sterile unit. It does not require any special storage conditions, making it convenient for deployment in emergency kits or public access locations where storage space and environmental controls may be limited.

• What regulatory pathway was followed for the Heartstart 1000S, and what classification does it hold under FDA regulations?

  The Heartstart 1000S follows the Traditional 510(k) clearance pathway and is classified as a Class III device under FDA regulations (21 CFR 870.5310). This classification reflects its role in treating life-threatening conditions like sudden cardiac arrest, requiring stringent regulatory oversight to ensure safety and effectiveness.

• Can the Heartstart 1000S be reused, or is it designed for single-use only?

  The Heartstart 1000S is explicitly designed for single-use only. This ensures reliability and safety, as reuse could compromise the device’s performance or introduce contamination risks in emergency situations where sterility and functionality are critical.