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Quantum Edge Pediatric Defirbrillation Electrodes

by Contour Medical Technology, Inc. 510(k)

Active United States

510(k) K970391

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970391 Date6 Mar 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MKJ
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Quantum Edge Pediatric Defibrillation Electrodes are designed as disposable electrodes for use with automated external defibrillators (non-wearable). These electrodes are specifically engineered to deliver defibrillation shocks to pediatric patients, ensuring appropriate energy delivery for their smaller body size and unique physiological characteristics. They are intended for use in emergency cardiac arrest situations where rapid defibrillation is critical to survival.

These electrodes are supplied as single-use, sterile devices and are intended for use in out-of-hospital and in-hospital settings by trained healthcare providers. They are classified under product code MKJ and are regulated under FDA 510(k) clearance (K970391) as substantially equivalent to the predicate device. The electrodes are packaged individually and must be stored according to manufacturer instructions to maintain sterility and functionality. No MRI safety information is provided in the specifications.

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