510(k) · Cleared
Recalled · Class II · 2024Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Jun 3, 2019 as substantially equivalent to K895379 (Physio-Control Corp., 1990) after a 264-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 3, 2019
- Review
- 264 days
- Class
- Class II
- Product code
- LDD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895379 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK895379 Low Energy DC - Defibrillator (Including Paddles)Physio-Control Corp. · 1990 · Recalled
- This deviceK182503 Sterilizable Internal Defibrillation Paddles for use with LIFEPAK…Physio-Control, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK203231 Switched Internal PaddlesPhilips North America, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K203231Switched Internal PaddlesPhilips North America, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895379 | Low Energy DC - Defibrillator (Including Paddles) | Physio-Control Corp. | 1990 | 1 |
| 0 (this device) | K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK… | Physio-Control, Inc. | 2019 | — |
| +1 | K203231 | Switched Internal Paddles | Philips North America, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895379 | Low Energy DC - Defibrillator (Including Paddles)Summary page 4…nt to the following previously cleared Internal Paddles: Predicate Device 510(k) Number(s)/ Clearance Date Internal Paddles and Paddle K895379 / cleared in 1990 Handles with Discharge Control… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203231 | Switched Internal Paddles | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2024 | Class II | Z-0142-2025 | Under Investigation by firm | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K203231 (Philips North America, LLC, 2021) has gone furthest, with 0 descendants of its own.
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. 2019, this device’s year, is highlighted.
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 Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182503: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182503
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026