Heartstart 2000

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

510(k) Number

K860676 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Heartstart 2000, Manual Defibrillator

  Class II

  FDA 510(k) K871136 Active Cleared 12 May 1987

• 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, Manual Medical Control Module

  Class II

  FDA 510(k) K871135 Active Cleared 12 May 1987

• Is the Heartstart 2000 designed for single-use or can it be reused after cleaning and maintenance?

  The Heartstart 2000 is explicitly described as a reusable medical device, not intended for single-use. Since it is non-sterile and intended for clinical and pre-hospital emergency care, proper cleaning and maintenance are required to ensure safe, repeated use. Always follow manufacturer guidelines for reprocessing to maintain functionality and compliance with regulatory standards.

• What types of environments is the Heartstart 2000 suitable for, and are there any restrictions related to MRI safety?

  The Heartstart 2000 is designed for use in clinical and pre-hospital emergency settings, but it is explicitly noted that it is not intended for environments where MRI safety is a concern. This means it should not be used near MRI machines or in areas where electromagnetic interference from MRI equipment could affect its operation or pose a risk to patients.

• Does the Heartstart 2000 require special training to operate, and if so, who is it intended for?

  Yes, the Heartstart 2000 is designed for use by trained responders and laypersons in emergency settings, but it requires proper training for operation. The device automatically analyzes heart rhythms and advises whether a shock is needed, making it accessible to users with basic training, though proficiency in defibrillation techniques is still recommended for optimal performance.

• How is the Heartstart 2000 supplied, and what should I consider regarding sterility?

  The Heartstart 2000 is supplied as a non-sterile reusable device. Since it is intended for emergency care, sterility is not a requirement for the device itself, but proper cleaning and maintenance protocols must be followed to prevent contamination and ensure safe reuse. Always adhere to the manufacturer’s instructions for reprocessing.

• What regulatory pathway was followed for the Heartstart 2000, and what class does it fall under?

  The Heartstart 2000 was authorized through the FDA 510(k) clearance process, specifically under Traditional Review with a decision code of SESE (Substantially Equivalent). It is classified as a Class III cardiovascular device under 21 CFR 870.5310, reflecting its critical role in emergency cardiac care and the stringent regulatory oversight required for such high-risk medical devices.