# K896919: Heartstart 3000

- Pathway: 510(k) (Traditional)
- Applicant: Laerdal Medical Corp.
- Decided: May 3, 1990 after 142 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
No predicates in its family tree.
26 later devices descend from it; 1 cites it directly.
4 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983393: Lifepak 500 Biphasic (1999), 25 descendants of its own
- K991910: Lifepak 12 Biphasic (1999), 22 descendants of its own
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker (2002), 21 descendants of its own
- K012428: Modification to: Lifepak 500 Automated External Defibrillator (2001), 21 descendants of its own
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 descendants of its own

Source page: https://510kreport.com/device/K896919
Methodology: https://510kreport.com/methodology