510(k) · Cleared
Recalled · Class II · 2019Philips Heartstart XL+, Philips Heartstart External Paddles, Philips Multifunction Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 16, 2012 after a 330-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 16, 2012
- Review
- 330 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 8
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK110825 Philips Heartstart XL+, Philips Heartstart External Paddles, Philips…Philips Medical Systems · 2012
- Descendant · cites it directly · 1 of its ownK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
- Descendant · 2 generations on · 0 of its ownK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110825 | Philips Heartstart XL+, Philips Heartstart External Paddles, Philips… | Philips Medical Systems | 2012 | — |
| +1 | K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring | Philips Medical Systems | 2015 | — |
| +2 | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 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 MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | HeartStart FR2 Named without a submission number | |
| * | — | HeartStart XL Named without a submission number | |
| * | — | HeartStart MRx Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2019 | Class II | Z-0498-2020 | Process control | The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy… |
| Oct 3, 2019 | Class II | Z-0608-2020 | Process control | Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test.… |
| Feb 7, 2018 | Class III | Z-0978-2018 | Labeling mix-ups | Update XL device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness. |
| Jun 5, 2015 | Class II | Z-2328-2015 | Device Design | Multiple software and hardware issues with device that can affect its function. |
| Apr 2, 2014 | Class II | Z-1438-2014 | Software design | Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy. |
| Mar 31, 2014 | Class II | Z-1439-2014 | Reprocessing Controls | A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy |
| Jan 24, 2014 | Class II | Z-1107-2014 | Component design/selection | HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling |
| Jan 28, 2013 | Class II | Z-0871-2013 | Software design | Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133659 (Philips Medical Systems, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The HeartStart XL + is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL± is suitable for use by medical personnel trained in basic life support that includes use of an…
Read the full statement (265 words)
The HeartStart XL + is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL± is suitable for use by medical personnel trained in basic life support that includes use of an AED.
When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart XL± is suitable for use by healthcare professionals trained in advanced life support.
The HeartStart XL+ is a defibrillator monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.
AED Mode is used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.
Synchronous defibrillation (cardioversion) is indicated for termination of atrial fibrillation.
The pacing option is indicated for treating patients with symptomatic bradycardia.
The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level.
The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure.
The ECG monitoring option is indicated to be used for monitoring, alarming, and recording of the patient's heart rate and morphology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110825: Philips Heartstart XL+, Philips Heartstart External Paddles, Philips Multifunction Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110825
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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