# K203231: Switched Internal Paddles

- Pathway: 510(k) (Special)
- Applicant: Philips North America, LLC
- Decided: Jan 11, 2021 after 70 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- 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 K895379 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021453: Heartstream XL Defibrillator/Monitor, Model #M4735A, Philips Medical Systems (2002) Summary page 4.
- K182503: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors, Physio-Control, Inc. (2019) Summary page 4.

## Indications for use
The Switched Internal Paddles are indicated for use in the treatment of ventricular fibrillation by manual defibrillation being provided directly to the heart during open-chest surgical procedures.

Source page: https://510kreport.com/device/K203231
Methodology: https://510kreport.com/methodology