Heartstart 2000, Manual Defibrillator

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

510(k) Number

K871136 ↗

FDA Product Code

LDD

Device Class

Class II

Regulation

21 CFR Part 870.5300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• First Medic Model 610P

  Class II

  FDA 510(k) K895185 Active Cleared 27 Oct 1989

• Heartstart 2000 Defibrillator Tester, ECG

  Class II

  FDA 510(k) K880780 Active Cleared 12 May 1988

• First Medic Mode 610

  Class III

  FDA 510(k) K883584 Active Cleared 6 Oct 1988

• Model 610 Modified

  Class II

  FDA 510(k) K903657 Active Cleared 4 Sep 1990

• Heartstart 2000

  Class III

  FDA 510(k) K860676 Active Cleared 30 Apr 1986

• Heartstart 2000, Manual Medical Control Module

  Class II

  FDA 510(k) K871135 Active Cleared 12 May 1987

• What is the Heartstart 2000 Manual Defibrillator used for?

  The Heartstart 2000 Manual Defibrillator is designed to deliver controlled electrical shocks to restore normal heart rhythm during cardiac arrest. It is specifically indicated for use in cardiovascular emergencies where defibrillation is required to treat life-threatening arrhythmias such as ventricular fibrillation or pulseless ventricular tachycardia.

• How is the Heartstart 2000 Manual Defibrillator supplied and what components does it include?

  The Heartstart 2000 Manual Defibrillator is supplied as a complete unit that includes paddles for delivering electrical shocks. It is a low-energy defibrillator designed for manual operation, meaning the clinician controls the energy level and timing of the shock delivery based on patient assessment.

• Is the Heartstart 2000 Manual Defibrillator a single-use or reusable device?

  The Heartstart 2000 Manual Defibrillator is a reusable device intended for multiple clinical uses. While the device itself is reusable, certain accessories such as paddle electrodes or conductive gel may be single-use depending on the specific accessory design and manufacturer instructions, which should be consulted for proper reprocessing and safety.

• What regulatory pathway was used for the Heartstart 2000 Manual Defibrillator and what is its classification?

  The Heartstart 2000 Manual Defibrillator received FDA 510(k) clearance under submission K871136 on May 12, 1987, with a determination of substantial equivalence. It is regulated as a Class II medical device under regulation number 870.5300 and product code LDD, which places it in the cardiovascular medical specialty category for defibrillators.