# K021453: Heartstream XL Defibrillator/Monitor, Model #M4735A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jul 3, 2002 after 58 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LIFEPAK 12 Defibrillator/Monitor: named in the summary without a submission number
- (no number) Heartstream XL Defibrillator/Monitor: named in the summary without a submission number

## Most influential descendants
- K203231: Switched Internal Paddles (2021), 0 descendants of its own
- K200849: Tempus LS - Manual (2020), 0 descendants of its own

## Recalls of this device
- Apr 20, 2020 · Class II · Z-2134-2020: 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 f
- Sep 11, 2012 · Class II · Z-0011-2013: 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 ba
- Jan 19, 2010 · Not classified · Z-1135-2010: Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy
- Mar 30, 2009 · Not classified · Z-1199-2009: 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: 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 
- Jun 11, 2007 · Not classified · Z-1128-2007: The ECG signal may become unusable to assess patient condition and need for therapy.
- Sep 2, 2003 · Not classified · Z-1226-03: Instructions For Use include addtional information on configuration for selecting Power on Lead
- Nov 25, 2002 · Not classified · Z-0343-03: Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.

## Indications for use
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.

Source page: https://510kreport.com/device/K021453
Methodology: https://510kreport.com/methodology