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Quik-Pace(r) Or Ex-Pace(tm) Pediatric Pacing Elec

FDA 510(k)

Class II (US FDA 510(k))

510(k) K912599

by Physio-Control Corp.

Identifiers

510(k) Number
K912599 FDA 510(k)
FDA Product Code
DRO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5550 FDA 510(k)
Regulation Number
870.5550 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Quik-Pace Pediatric Pacing Electrode is an external transcutaneous (non-invasive) cardiac pacemaker electrode designed for temporary pacing of pediatric patients. It delivers electrical stimulation to the heart to maintain or restore a normal heart rhythm in cases of bradycardia or other pacing indications.

This device is supplied as a single-use electrode and is intended for use with external defibrillators or monitors. It is classified as a Class II medical device under FDA regulations (21 CFR 870.5550) and holds a 510(k) clearance (K912599) for substantial equivalence. The electrode is part of the DRO product code category and is manufactured by Physio-Control Corp.

Frequently asked questions

What is the Quik-Pace Pediatric Pacing Electrode used for in clinical practice?

The Quik-Pace Pediatric Pacing Electrode is designed for temporary transcutaneous (non-invasive) cardiac pacing in pediatric patients. It delivers electrical stimulation to help maintain or restore a normal heart rhythm during cases of bradycardia or other pacing indications where immediate intervention is required.

Is the Quik-Pace Pediatric Pacing Electrode intended for single-use or can it be reused?

The Quik-Pace Pediatric Pacing Electrode is explicitly supplied as a single-use device. This design ensures patient safety and sterility, as reuse could compromise its performance and introduce infection risks.

What types of devices is this electrode compatible with, and how is it supplied?

This electrode is intended for use with external defibrillators or cardiac monitors. It is supplied as a standalone, single-use electrode, meaning no additional components are required beyond the electrode itself and a compatible pacing device.

How is the sterility of the Quik-Pace Pediatric Pacing Electrode maintained?

Since the Quik-Pace Pediatric Pacing Electrode is a single-use device, sterility is maintained through its sterile packaging. Each electrode is individually packaged to prevent contamination before use, ensuring a clean and safe application for pediatric patients.

What regulatory pathway was followed for FDA clearance of this device?

The Quik-Pace Pediatric Pacing Electrode received FDA clearance through a 510(k) submission, specifically under the Traditional review pathway. It was deemed substantially equivalent to a predicate device and falls under the product code DRO, with a classification as a Class II medical device (21 CFR 870.5550).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Quik-pace (R) or Ex-pace (Tm) Pediatric Pacing Elec, PDF K912599 - Quik-pace(R) or Ex-pace(Tm) Pediatric Pacing Elec, Quik-pace (R) or Ex-pace (Tm) Pediatric Pacing Elec, Physio-Control Electrodes Pediatric EDGE System RTS with QUIK-COMBO, PadPro Adult and Pediatric Multi-Function ECG Electrodes | CONMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K912599 24 fields · synced Sep 19, 2026