# K072812: Philips Heartstart Smartpads Iii

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Feb 26, 2008 after 148 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020715 (2002). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050004: Philips Heartstart FRX Defibrillator, Model 861304, Philips Medical Systems (2005) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Philips HeartStart SmartPads III is indicated for external defibrillation, pacing, monitoring and cardioversion. The SmartPads III is intended for adults and children over 8 years of age or greater than 55 pounds (25kg) with all compatible defibrillators. 'he SmartPads III is also intended for children of all ages when used with a Philips Medical System model FRx equipped with an Infant/Child Key or with other compatible defibrillators which incorporate adjustable defibrillation energy functionality The device is non-sterile and single-use only.

Source page: https://510kreport.com/device/K072812
Methodology: https://510kreport.com/methodology