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510(k) K002445

LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES by Medtronic Physio-Control Corp. — Product Code MKJ

K002445 is an FDA 510(k) premarket notification submitted by Medtronic Physio-Control Corp. for the device "LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES". The FDA issued a decision of ST on January 31, 2001. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Medtronic Physio-Control Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
January 31, 2001
Date Received
August 9, 2000
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 Medtronic Physio-Control Corp.

  • K040775 — LIFEPAK 12 (April 23, 2004)
  • K033275 — LIFEPAK 12, 20, 500, CR PLUS (November 6, 2003)
  • K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODES (December 13, 2002)
  • K012274 — MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (February 5, 2002)
  • K011144 — LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (December 3, 2001)
  • K012428 — MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (September 28, 2001)
  • K010918 — LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (August 23, 2001)

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