# K951593: Lifepak 11

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Dec 29, 1995 after 267 days
- Product code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))
- Device class: 2
- Regulation: 21 CFR 870.5550
- Recalls of this device: 1 (0 Class I)
- 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; 2 cite 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973486: Life Pak 12 (1998), 24 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
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 descendants of its own
- K040775: Lifepak 12 (2004), 10 descendants of its own

## Recalls of this device
- Feb 27, 2008 · Not classified · Z-1567-2008: Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.

Source page: https://510kreport.com/device/K951593
Methodology: https://510kreport.com/methodology