# K030417: Disposable Sterile Internal Defibrillation Paddles (Switched-Large), Disposable Sterile Internal Defibrillation Paddles

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: May 9, 2003 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CodeMaster XL+ Defibrillator/Monitor, Philips Medical Systems (formerly HP), with internal paddle models M1742A, M1743A, M1744A, M1785A, M1786A, and M1787A: named in the summary without a submission number

## Indications for use
The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.

Source page: https://510kreport.com/device/K030417
Methodology: https://510kreport.com/methodology