# K962359: Lifepak 300

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Nov 6, 1997 after 505 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: 1 generation back to K925936 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925936: Lifepak 300 Automatic Advisory Defrillator, Physio-Control Corp. (1994) Summary page 1.

## Indications for use
For emergency treatment of patients in cardiac arrest who are unconscious and lack pulse and spontaneous breath. The device may be used for automated ECG analysis or, alternatively as a standard cardiac monitor formanual ECG

Source page: https://510kreport.com/device/K962359
Methodology: https://510kreport.com/methodology