# K992543: Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card, Single Bay Adapter, Defibrillator Pads Cable

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: May 18, 2000 after 293 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) HP CodeMaster 100 Defibrillator/Monitor: named in the summary without a submission number
- (no number) HP Heartstream ForeRunner AED: named in the summary without a submission number
- (no number) HP CodeMaster XL: named in the summary without a submission number
- (no number) HP Viridia Telemetry System: named in the summary without a submission number

## Most influential descendants
- K121853: Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories (2012), 0 descendants of its own

## Indications for use
The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation. This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-autharized emergency medical response. It must be used by or on the order of a physician. The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. Thesge trials support the waveform’s effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials. AED Therapy: To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless. The AED mode is not intended for use on children less than 8 years of age. For chiidren older than 8 years, the American Heart Association recommends that standard operating procedures for AEDs be followed. American Hearnt Association. Textbook of Advanced Cardiac Life Support. Dallas, Tex: AHA;1997. Pacing: Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be heipful in patients with asystale, if performed early. Sp0O. Monitoring: SpO; monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.

Source page: https://510kreport.com/device/K992543
Methodology: https://510kreport.com/methodology