510(k) · Cleared
ClearedSwitched Internal Paddles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips North America, LLC · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Jan 11, 2021 as substantially equivalent to K021453 (Philips Medical Systems, 2002) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jan 11, 2021
- Review
- 70 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895379 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK895379 Low Energy DC - Defibrillator (Including Paddles)Physio-Control Corp. · 1990 · Recalled
- 1 generation backK182503 Sterilizable Internal Defibrillation Paddles for use with LIFEPAK…Physio-Control, Inc. · 2019 · Recalled
- This deviceK203231 Switched Internal PaddlesPhilips North America, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895379 | Low Energy DC - Defibrillator (Including Paddles) | Physio-Control Corp. | 1990 | 1 |
| −1 | K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK… | Physio-Control, Inc. | 2019 | 1 |
| 0 (this device) | K203231 | Switched Internal Paddles | Philips North America, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K021453 | Heartstream XL Defibrillator/Monitor, Model #M4735ASummary page 4…DD III. Predicate Device Information Primary Predicate Name HeartStream XL Defibrillator/Monitor 510(k) Submission No. K021453 Classification Class II (for LDD product code) 21 CFR 870.… | 2002 |
| * | K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsSummary page 4…izable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors 510(k) Submission No. K182503 Classification Class II 21 CFR 870.5300, DC-defibrillator… | 2019 |
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.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 29.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K021453.
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. 2021, 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 Switched Internal Paddles are indicated for use in the treatment of ventricular fibrillation by manual defibrillation being provided directly to the heart during open-chest surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203231: Switched Internal Paddles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203231
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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