HeartStart FRx Defibrillator

FDA premarket approval P180028 · Automated external defibrillators (non-wearable)

PMA numberP180028

Approval

Applicant
Philips Medical Systems
Received
August 3, 2018
Decision date
May 11, 2020 (APPR)
Supplements
19, latest May 21, 2026
Product code
MKJ – Automated External Defibrillators (Non-Wearable)

Official FDA PMA record

Approval order statement

Approval for the HeartStart FRx Defibrillator (Model 861304). The device is indicated for use on potential victims of sudden cardiac arrest (SCA) with the following symptoms:1) Unconsciousness; and2) Absence of normal breathingThe HeartStart FRx (Model 861304) is indicated for adults over 55 pounds (25 kg). The Model 861304 is also indicated for infants and children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key (Model 989803139311). If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, proceed using adult treatment without the infant/child key.