510(k) · Cleared
ClearedBooker Box, Model Pad 5010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Jul 20, 2000 after a 300-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 20, 2000
- Review
- 300 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (182 words)
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
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993205: Booker Box, Model Pad 5010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993205
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026