510(k) · Cleared
ClearedCodemaster XL + XL W/Shock Advisory Option
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 7, 1996 as substantially equivalent to K892005 (Physio-Control Corp., 1989) after a 193-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- May 7, 1996
- Review
- 193 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K892005 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK892005 Shock Advisory Adapter for Use W/Lifepak 9Physio-Control Corp. · 1989
- This deviceK954957 Codemaster XL + XL W/Shock Advisory OptionHewlett-Packard Co. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892005 | Shock Advisory Adapter for Use W/Lifepak 9 | Physio-Control Corp. | 1989 | — |
| 0 (this device) | K954957 | Codemaster XL + XL W/Shock Advisory Option | Hewlett-Packard Co. | 1996 | — |
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? (1)
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 |
|---|---|---|---|
| * | K892005 | Shock Advisory Adapter for Use W/Lifepak 9Summary page 1…se of the Physio Control LifePak 9 and 9A defibrillator/monitors used with the Shock Advisory Adapter which received FDA's substantial equivalence determination under K#892005. CodeMaster defibrillators with Shock Advisory capability may be operated as standard manual defibrillators. Standard CodeMaster… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 Shock Advisory Option for CodeMaster defibrillators is intended for use by medical personnel who have completed training and certification requirements applicable to the use of a semi-automatic defibrillator and under a physician approved protocol. It is indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by unconsciousness, absence of breathing, and absence of pulse. The Shock Advisory Option is…
Read the full statement (424 words)
The Shock Advisory Option for CodeMaster defibrillators is intended for use by medical personnel who have completed training and certification requirements applicable to the use of a semi-automatic defibrillator and under a physician approved protocol. It is indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by unconsciousness, absence of breathing, and absence of pulse. The Shock Advisory Option is intended for use in terminating ventricular fibrillation by application of a brief electrical shock to the heart via external adhesive electrodes.
The Shock Advisory Option for CodeMaster is contraindicated for use on patients that are conscious, breathing, pulsatile, or have an implanted pacemaker. The Shock Advisory Option is not intended for pediatric use.
The intended use of the CodeMaster Shock Advisory Option is identical to the intended use of the Physio Control LifePak 9 and 9A defibrillator/monitors used with the Shock Advisory Adapter which received FDA's substantial equivalence determination under K#892005.
CodeMaster defibrillators with Shock Advisory capability may be operated as standard manual defibrillators. Standard CodeMaster defibrillator/monitors are low energy DC-defibrillators (with interchangeable paddles) as described in 21 CFR 870.5300. They are also intended for use by trained medical personnel under a physician approved protocol. Standard CodeMaster defibrillators are intended for use in terminating ventricular fibrillation by application of a brief electrical shock to the heart via external or internal electrodes. They may also be used to treat arrhythmias. This procedure, called synchronized cardioversion, requires that the defibrillator discharge occur on the ECG R wave in order to avoid inducing ventricular fibrillation.
The M1722A/B and the M2475B are also intended for external, non-demand or demand pacing if the patient is in a life-threatening asystole, profound bradycardia or any other condition in which the clinician determines that pacing must be initiated immediately. The noninvasive pacer is intended for adult or pediatric use. With regards to pediatric pacing, a determination of the suitability of external pacing for any patient must be made by the clinician. Also, the correct rate and current levels for the patient must be determined and set by the physician.
The M1722A/B and the M2475B provide pulse oximetry. The pulse oximeter is an arterial oxygen-saturation and pulse rate measurement capability which augments the ECG monitoring capability of the device. The pulse oximeter produces the numeric for the oxygen saturation value and pulse rate. The pulse oximeter is intended to be used to determine the oxygen saturation of the blood in cases where the patient's oxygenation is of direct concern and to determine the pulse rate.
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/K954957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954957: Codemaster XL + XL W/Shock Advisory Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954957
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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