# K993205: Booker Box, Model Pad 5010

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: Jul 20, 2000 after 300 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 Booker Bax is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes. Provides simultaneous connection to two defibrillators, which allows placement of a set of back-up electrodes Provides connection to generic physiologic monitor recorder cable for unipolar recording from using a back electrode. Used in Hospitals/EP Laboratories Used with manual defibrillators and has been tested with the following devices: Hewlett Packard CodeMaster Hewlett Packard 7600, 7800 Zoll PD1200, PD1400, “M" Series Siemans 410 PhysioControl LifePak LPS, LP6, LP8, LP9, LP10 and LP 12

Source page: https://510kreport.com/device/K993205
Methodology: https://510kreport.com/methodology