# K954957: Codemaster XL + XL W/Shock Advisory Option

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: May 7, 1996 after 193 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
Longest line of descent: 1 generation back to K892005 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892005: Shock Advisory Adapter for Use W/Lifepak 9, Physio-Control Corp. (1989) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K954957
Methodology: https://510kreport.com/methodology