# K973486: Life Pak 12

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Jan 9, 1998 after 116 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: 2 generations back to K921669 (1993). 7 ancestors in all.
24 later devices descend from it; 8 cite it directly.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951593: Lifepak 11, Physio-Control Corp. (1995) Summary page 1.
- K912189: Likepak 11 Cardiac Monit/Lifenet RS100 Rec Station, Physio-Control Corp. (1992) Summary page 1.
- K950483: Hewlett Packard M2475B Codemaster 100 Defibrillator/Monitor, Hewlett-Packard Co. (1995) Summary page 2.
- K903644: Series 1500 12-Lead Analysis Option, Marquette Electronics, Inc. (1991) Summary page 2.
- K964750: Eagle 4000 Patient Monitor, Marquette Electronics, Inc. (1997) Summary page 2.

## Most influential descendants
- K991910: Lifepak 12 Biphasic (1999), 22 descendants of its own
- 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

## Recalls of this device
- May 11, 2011 · Not classified · Z-2625-2011: The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications.
- Feb 27, 2008 · Not classified · Z-1567-2008: Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.
- 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
The AED mode is to be used only on patients in cardiopulmonary arrest. Thg patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. Defibrillation therapy is used as a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating supraventricular tachycardia, atrial fibrillation, atrial flutter, and, in relatively stable patients, ventricular tachycardia. Noninvasive pacing is used as a means of treating symptématic bradycardia and asystole. The 3 and 4 wire ECG allows for identification or interpetation 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 6f patients with acute myocardial infarction. A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO,). It is used for monitoring patients who are at risk of developing hypoxemia.

Source page: https://510kreport.com/device/K973486
Methodology: https://510kreport.com/methodology