# K040904: Philips Heartstart Home Defibrillator, Model M5068A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 16, 2004 after 162 days
- Product code: NSA (Over-The-Counter Automated External Defibrillator)
- 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 K003565 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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) Summary page 3.
- K003565: Heartstream FR2 Aed, Model M3860A,M3861A, Agilent Technologies, Inc. (2000) Summary page 3.

## Most influential descendants
- 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.
- Feb 6, 2014 · Class II · Z-1232-2014: Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamin
- Apr 30, 2010 · Not classified · Z-1917-2010: Seventeen AEDs failed production line testing (Final Acceptance Test).
- Nov 2, 2009 · Not classified · Z-1196-2010: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- Apr 30, 2008 · Not classified · Z-1779-2008: Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrill
- Apr 30, 2008 · Not classified · Z-1781-2008: Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrill

## Indications for use
The HeartStart Home Defibrillator should be used to treat someone who you think may be a victim of sudden cardiac arrest. A person in sudden cardiac arrest: • does not respond when shaken, and • is not breathing normally. If in doubt, apply the pads.

Source page: https://510kreport.com/device/K040904
Methodology: https://510kreport.com/methodology