Life Pak 12
FDA 510(k) K973486 · Physio-Control Corp.
510(k) numberK973486
Submission
- Device name
- Life Pak 12
- Applicant
- Physio-Control Corp.
Redmond, WA, US - Received
- September 15, 1997
- Decision date
- January 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
Other 510(k)s with product code MKJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143714 | Powerheart G5 AEDMKJ · Traditional | Cardiac Science Corporation | 05/04/2015SE |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K150055 | OneStep Pediatric CPR Multi-Function ElectrodeMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K142709 | samaritan PAD 450PMKJ · Traditional | Heartsine Technologies, Inc. | 03/27/2015SE |
| K133659 | Heartstart Xl+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringMKJ · Traditional | Philips Medical Systems | 01/23/2015SE |
| K133239 | Zoll E SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 01/16/2015SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | Physio-Control, Inc. | 12/19/2014SE |
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | R & D Batteries, Inc. | 12/08/2014SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | ZOLL Medical Corporation | 12/03/2014SE |
| K142803 | Skintact, various other tradenamesMKJ · Traditional | Leonhard Lang GmbH | 12/02/2014SE |
More from Leonhard Lang GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333)MPD · Special | 10/14/2025SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | 04/30/2024SE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | 06/03/2019SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | 12/19/2014SE |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorMKJ · Traditional | 08/21/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | 10/11/2012SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
Questions and answers
When was Life Pak 12 cleared by the FDA?
Life Pak 12 (K973486) received a 510(k) decision of Substantially Equivalent on January 9, 1998, 116 days after the submission was received.
What is the product code of K973486?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.