510(k) K150055

OneStep Pediatric CPR Multi-Function Electrode by Bio-Detek, Inc. — Product Code MKJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 2, 2015
Date Received: January 12, 2015
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 Bio-Detek, Inc.

K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE (October 10, 2014)
K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0 (November 16, 2010)
K071321 — POCKETCPR (September 12, 2007)
K040056 — BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 (April 9, 2004)
K040256 — PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 (April 9, 2004)
K033771 — BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR (February 27, 2004)
K984582 — ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX (March 16, 1999)
K990106 — ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES (February 26, 1999)
K981802 — ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 (November 25, 1998)

Other clearances for product code MKJ

K143714 — Powerheart G5 AED (May 4, 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)
K141231 — ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (November 25, 2014)