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510(k) K954504

K-DEFIB/PACE PEDIATRIC ELECTRODE by Katecho, Inc. — Product Code MKJ

K954504 is an FDA 510(k) premarket notification submitted by Katecho, Inc. for the device "K-DEFIB/PACE PEDIATRIC ELECTRODE". The FDA issued a decision of Substantially Equivalent on November 17, 1995. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Katecho, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1995
Date Received
September 28, 1995
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 Katecho, Inc.

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K010543 — KM-30 TENS ELECTRODE (May 23, 2001)
  • K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (December 14, 2000)
  • K002806 — K-DEFIB/PACE, MODEL KDP-60A (November 21, 2000)
  • K000870 — KM-10 TENS ELECTRODE (November 7, 2000)
  • K993745 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (February 3, 2000)
  • K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (August 23, 1999)
  • K981737 — K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (December 9, 1998)
  • K934692 — K-DEFIB/PACE PEDIATRIC ELECTRODE (January 24, 1995)
  • K940801 — K-KLIP (August 3, 1994)

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