510(k) · Cleared
Recalled · Class II · 2020Heartstream XL Defibrillator/Monitor, Model #M4735A
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 Jul 3, 2002 after a 58-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 3, 2002
- Review
- 58 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 8
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK021453 Heartstream XL Defibrillator/Monitor, Model #M4735APhilips Medical Systems · 2002
- Descendant · cites it directly · 0 of its ownK203231 Switched Internal PaddlesPhilips North America, LLC · 2021
- Descendant · cites it directly · 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) | K021453 | Heartstream XL Defibrillator/Monitor, Model #M4735A | Philips Medical Systems | 2002 | — |
| +1 | K203231 | Switched Internal Paddles | Philips North America, LLC | 2021 | — |
| +1 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | — | LIFEPAK 12 Defibrillator/Monitor Named without a submission number | |
| * | — | Heartstream XL Defibrillator/Monitor Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2020 | Class II | Z-2134-2020 | Device Design | Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather… |
| Sep 11, 2012 | Class II | Z-0011-2013 | Nonconforming Material/Component | HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. |
| Jan 19, 2010 | Not classified | Z-1135-2010 | Nonconforming Material/Component | Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy |
| Mar 30, 2009 | Not classified | Z-1199-2009 | Nonconforming Material/Component | Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy. |
| Sep 4, 2007 | Not classified | Z-0062-2008 | Package design/selection | Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly. |
| Jun 11, 2007 | Not classified | Z-1128-2007 | Nonconforming Material/Component | The ECG signal may become unusable to assess patient condition and need for therapy. |
| Sep 2, 2003 | Not classified | Z-1226-03 | Other | Instructions For Use include addtional information on configuration for selecting Power on Lead |
| Nov 25, 2002 | Not classified | Z-0343-03 | Other | Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected. |
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, K203231 (Philips North America, LLC, 2021) has gone furthest, with 0 descendants 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.
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 Heartstream XL Defibrillator/Monitor is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has…
Read the full statement (254 words)
The Heartstream XL Defibrillator/Monitor is for use for the termination of ventricular tachycardia and ventricular fibrillation.
The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.
AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.
The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.
Synchronized defibrillation is indicated for termination of atrial fibrillation. The SMART Biphasic waveform utilized in the Heartstream XL has undergone clinical testing demonstrating its safety and effectiveness for cardioversion of atrial fibrillation.
There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications.
Pacing: Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
SpO2 Monitoring: SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021453: Heartstream XL Defibrillator/Monitor, Model #M4735A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021453
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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