First Medic Mode 610

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

510(k) Number

K883584 ↗

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

• 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 primary purpose of the First Medic Mode 610, and who is it intended for?

  The First Medic Mode 610 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 is intended for emergency use outside of clinical settings, making it suitable for trained personnel or lay responders in non-hospital environments like public spaces, workplaces, or homes.

• Is the First Medic Mode 610 a single-use or reusable device, and how should it be maintained?

  The First Medic Mode 610 is a reusable medical instrument, meaning it is not designed for single-use. Proper storage and maintenance are required as outlined by the manufacturer to ensure reliability and safety. Since it is a high-risk Class III device, adherence to maintenance protocols is critical for continued functionality.

• What regulatory pathway was followed for FDA clearance of this device, and when was it authorized?

  The First Medic Mode 610 was cleared through the FDA’s 510(k) pathway under the traditional review process, with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. It received clearance on October 6, 1988, with the K883584 number, and was authorized for commercial distribution in 1988 under 21 CFR 870.5310.

• Can this device be used in an MRI environment, and what special considerations should be noted?

  The First Medic Mode 610 is not indicated for MRI use. Since it is an electronic medical device, exposure to MRI environments could pose risks to both the device and the patient. Users should ensure it is stored and operated in non-MRI environments to avoid interference or safety hazards.

• What product code and classification does this device fall under in FDA records?

  The First Medic Mode 610 is classified under product code MKJ and is categorized as a Class III medical device due to its high-risk, life-sustaining nature. This classification aligns with its role as an Automated External Defibrillator (Non-Wearable) and reflects its regulatory requirements for stringent oversight.