# K042302: Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll Autoclavable

- Pathway: 510(k) (Special)
- Applicant: Zoll Medical Corp
- Decided: Oct 26, 2004 after 62 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 are to be used with interchangeable electrodes and a manually operated ZOLL Defibrillator to defibrillation therapy directly to the heart during surgical procedures. When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature the ZOLL Autoclavable Internal Handles allows the defibrillator to operate only as a manual device The ZOLL Autoclavable Internal Handles are intended for use by or under the direction of a physician. The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to provide defibrillation therapy directly to 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 allows 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, The ZOLL Autoclavable External Paddles are to be used with manually operated ZOLL M Series Defibrillator products to perform closed chest defibrillation of a patient when sterilization of the paddles is required either before or after the defibrillation event. The ZOLL Autoclavable External Paddles are intended for use by trained personnel and are for use on Adult patients only. The ZOLL Autoclavable External Paddles are intended for use by or under the direction of a physician.

Source page: https://510kreport.com/device/K042302
Methodology: https://510kreport.com/methodology