# K032691: Zoll Autoclavable Internal Handles

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Nov 13, 2003 after 72 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to defibrillate the heart during surgical procedures. When used with a ZOLL defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allow the defibrillator to operate only as a manual device. The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.

Source page: https://510kreport.com/device/K032691
Methodology: https://510kreport.com/methodology