# K991910: Lifepak 12 Biphasic

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Sep 3, 1999 after 88 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921669 (1993). 15 ancestors in all.
22 later devices descend from it; 8 cite it directly.
4 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973486: Life Pak 12, Physio-Control Corp. (1998) Summary page 1.
- K983393: Lifepak 500 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K955628: Fore Runner External Defibrillator/Defibrillator Pads, Heartstream, Inc. (1996) Summary page 1.
- (no number) Mine Safety defibrillator: named in the summary without a submission number

## Most influential descendants
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker (2002), 21 descendants of its own
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 descendants of its own
- K040775: Lifepak 12 (2004), 10 descendants of its own
- K041459: Lifepak 12 Defibrillator/Monitor (2004), 9 descendants of its own
- K063510: Lifepak 12 Defibrillator/Monitor (2007), 7 descendants of its own

## Recalls of this device
- May 8, 2008 · Not classified · Z-1858-2008: The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.
- Jan 15, 2005 · Not classified · Z-0495-05: The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
- Jan 27, 2003 · Not classified · Z-0542-03: Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.

## Indications for use
Defibrillation therapy is used as a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The AED mode is not intended for use on children less than eight years of age, per AHA guidelines. Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole. The 3 and 4 wire ECG allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The 12-lead electrocardiogram (ECG) is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction. A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO₂). It is used for monitoring patients who are at risk of developing hypoxemia.

Source page: https://510kreport.com/device/K991910
Methodology: https://510kreport.com/methodology