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Temporary Pacemaker Ground Wire

FDA 510(k)

Class III (US FDA 510(k))

510(k) K852119

by Scholten Surgical Instruments, Inc.

Identifiers

510(k) Number
K852119 FDA 510(k)
FDA Product Code
DTB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Temporary Pacemaker Ground Wire is a flexible insulated electrical conductor designed to connect an external temporary pacemaker pulse generator to the patient’s heart. It facilitates temporary cardiac pacing to manage bradycardia during surgical or diagnostic procedures, ensuring stable heart rhythm when endogenous conduction is compromised.

This device is intended for single-use in hospital operating rooms, electrophysiology labs, or cardiac catheterization suites. Supplied sterile and packaged for one-time use, it adheres to FDA 510(k) clearance (K852119) under the classification of Class III (DTB). No MRI safety or reusable specifications are noted in the regulatory data.

Frequently asked questions

What is the Temporary Pacemaker Ground Wire used for in clinical settings?

The Temporary Pacemaker Ground Wire connects an external temporary pacemaker pulse generator to a patient’s heart during surgical or diagnostic procedures. It ensures stable heart rhythm by facilitating temporary cardiac pacing when the patient’s natural conduction system is compromised, such as during bradycardia episodes.

Is this device intended for reuse or single-use, and how is it supplied?

This device is explicitly designed for single-use only and is supplied sterile, packaged for one-time use in hospital settings like operating rooms, electrophysiology labs, or cardiac catheterization suites. The sterile packaging ensures safety and compliance with clinical protocols.

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

The Temporary Pacemaker Ground Wire received FDA 510(k) clearance (K852119) under the Traditional review pathway, classified as Class III (DTB). The submission was reviewed by the Cardiovascular (CV) Advisory Committee in 1985, with a decision confirming it as substantially equivalent to a predicate device.

Where would this device typically be used, and what environments are recommended?

This device is intended for use in hospital-based environments, including operating rooms, electrophysiology labs, and cardiac catheterization suites. Its flexible, insulated design makes it suitable for temporary pacing during procedures where stable cardiac rhythm is critical, such as surgeries or diagnostic evaluations.

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: Temporary Pacemaker Ground Wire - Scholten Surgical Instruments | FDA ..., TEMPORARY PACEMAKER GROUND WIRE (K852119) — FDA 510 (k) | Innolitics, TEMPORARY PACEMAKER GROUND WIRE 510 (k) K852119 - FDA.report, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Scholten Surgical Instruments, Inc.

Sources (1)

  • FDA 510(k) K852119 24 fields · synced Sep 18, 2026