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510(k) K122600

LIFEPAK 1000 DEFIBRILLATOR by Physio-Control, Inc. — Product Code MKJ

K122600 is an FDA 510(k) premarket notification submitted by Physio-Control, Inc. for the device "LIFEPAK 1000 DEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on October 11, 2012. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Physio-Control, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2012
Date Received
August 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type

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 unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by Physio-Control, Inc.

  • K253099 — LIFEPAK 15 AC Power Adapter (41577-000333) (October 14, 2025)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (August 21, 2013)
  • K123597 — TRUECPR COACHING DEVICE (April 17, 2013)
  • K103567 — LIFEPAK 15 MONITOR/DEFIBRILLATOR (March 22, 2011)
  • K102972 — LIFEPAK 12 (December 22, 2010)
  • K102757 — LIFENET SYSTEM (November 5, 2010)
  • K093925 — LIFENET SYSTEM (January 12, 2010)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)

FDA data resources