# K050004: Philips Heartstart FRX Defibrillator, Model 861304

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Feb 25, 2005 after 54 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020715 (2002). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020715: Philips M5066A and M5068A, Philips Medical Systems (2002)

## Most influential descendants
- K072812: Philips Heartstart Smartpads Iii (2008), 3 descendants of its own
- K111693: Philips Heartstart FR3 Automated External Defibrillator (2011), 2 descendants of its own
- K130684: Philips Heartstart FR3 Automated External Defibrillator (2013), 0 descendants of its own
- K120350: Extended Life Battery (2012), 0 descendants of its own
- K091548: Amco Replacement Battery for Philips Medical Models BT1 and M5070A (2009), 0 descendants of its own

## Recalls of this device
- Sep 10, 2019 · Class II · Z-1272-2020: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
- Sep 10, 2019 · Class II · Z-1271-2020: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
- Mar 14, 2018 · Class II · Z-1913-2018: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
- Jul 26, 2012 · Class II · Z-0642-2013: Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A an
- Apr 30, 2010 · Not classified · Z-1915-2010: Seventeen AEDs failed production line testing (Final Acceptance Test).
- Nov 2, 2009 · Not classified · Z-1193-2010: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- Aug 7, 2008 · Not classified · Z-0432-2011: The affected device may not deliver appropriate defibrillation therapy.

## Indications for use
The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is: * Unresponsive when shaken * Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key.

Source page: https://510kreport.com/device/K050004
Methodology: https://510kreport.com/methodology