# K182503: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control, Inc.
- Decided: Jun 3, 2019 after 264 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895379 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895379: Low Energy DC - Defibrillator (Including Paddles), Physio-Control Corp. (1990) Summary page 4.

## Most influential descendants
- K203231: Switched Internal Paddles (2021), 0 descendants of its own

## Recalls of this device
- Aug 9, 2024 · Class II · Z-0142-2025: Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrill

## Indications for use
The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.

Source page: https://510kreport.com/device/K182503
Methodology: https://510kreport.com/methodology