510(k) · Cleared
ClearedHeartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card, Single Bay Adapter, Defibrillator Pads Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on May 18, 2000 after a 293-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 18, 2000
- Review
- 293 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK992543 Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data…Hewlett-Packard Co. · 2000
- Descendant · cites it directly · 0 of its ownK121853 Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992543 | Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card… | Hewlett-Packard Co. | 2000 | — |
| +1 | K121853 | Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | — | HP CodeMaster 100 Defibrillator/Monitor Named without a submission number | |
| * | — | HP Heartstream ForeRunner AED Named without a submission number | |
| * | — | HP CodeMaster XL Named without a submission number | |
| * | — | HP Viridia Telemetry System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121853 | Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories | 2012 | 0 |
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?
- Of its descendants, K121853 (Defibtech, LLC, 2012) 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 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…
Read the full statement (228 words)
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.
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/K992543 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992543: Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card, Single Bay Adapter, Defibrillator Pads Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992543
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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