Heartstart 1000

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

510(k) Number

K883341 ↗

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 1000S

  Class III

  FDA 510(k) K883344 Active Cleared 12 Sep 1988

• Modified Heartstart 2000 Defibrillation Electrode

  Class II

  FDA 510(k) K900169 Active Cleared 26 Jan 1990

• What is the primary purpose of the Heartstart 1000 in emergency cardiac care settings?

  The Heartstart 1000 is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It automatically analyzes heart rhythms and either advises or delivers shocks when necessary, making it a critical tool for prehospital and clinical emergency response.

• Is the Heartstart 1000 intended for reuse, or is it meant for single-use only?

  The Heartstart 1000 is explicitly designed for single-use in prehospital and clinical environments, such as emergency medical services and cardiac arrest scenarios. This ensures safety and reliability for each emergency intervention.

• What regulatory pathway was followed for the FDA clearance of the Heartstart 1000?

  The Heartstart 1000 received a Traditional 510(k) clearance (K883341) under FDA regulation 870.5310, which is the standard pathway for demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class III medical device under the Cardiovascular specialty.

• Does the Heartstart 1000 require special training for operation, and why?

  Yes, the Heartstart 1000 requires proper training for operation because it is a Class III medical device used in life-threatening situations like sudden cardiac arrest. Effective use of the device—including proper rhythm analysis and shock delivery—demands familiarity with its automated functions to ensure accurate and timely intervention.

• Are there multiple models or sizes available for the Heartstart 1000, or is it a single unified device?

  The provided data does not specify multiple models or sizes for the Heartstart 1000, indicating it is likely a single unified device designed for broad use in prehospital and clinical settings. However, the extensive list of registration numbers suggests it may have undergone various updates or configurations over time, but no distinctions in sizing or model variations are mentioned.