510(k) · Cleared
ClearedZoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll Autoclavable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corp · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Oct 26, 2004 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 26, 2004
- Review
- 62 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 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…
Read the full statement (231 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042302: Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll Autoclavable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042302
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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