Model EC4542G Miniature

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K896352 ↗

FDA Product Code

DTE

Device Class

Class II

Regulation

21 CFR Part 870.3600

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 4205 Pulse Generator Surgical Exten Cable

  Class III

  FDA 510(k) K912545 Active Cleared 26 Jul 1991

• Model 4815 Adapter

  Class II

  FDA 510(k) K002496 Active Cleared 10 Oct 2000

• Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528

  Class II

  FDA 510(k) K001180 Active Cleared 27 Jun 2000

• Model 4800 Accupace Pacing System Analyer

  Class II

  FDA 510(k) K925143 Active Cleared 27 Sep 1994

• Model 3110 Heart Wire & 3110P Pediatric Heart Wire

  Class II

  FDA 510(k) K890988 Active Cleared 25 Aug 1989

• Pace Implant. Lead/Tined/Atrial/J/Model 3290

  Class III

  FDA 510(k) K864153 Active Cleared 6 Jan 1987

See all devices from Pace Medical →

• What is the primary use of the Model EC4542G Miniature External Pulse-Generator Pacemaker, and where is it intended to be used?

  The Model EC4542G is designed to provide temporary cardiac pacing support for patients experiencing bradycardia or other temporary conduction disorders, helping stabilize heart rhythm during clinical procedures or post-operative recovery. It is explicitly intended for in-hospital use only and must be operated by qualified medical personnel. The device ensures short-term stabilization but requires immediate availability of additional life-support equipment like defibrillation, intravenous infusion, intubation, and oxygen administration.

• Is the Model EC4542G meant for single-use or can it be reused, and what does the manufacturer specify about sterility?

  The regulatory data for the Model EC4542G indicates it can be supplied as either single-use or reusable, but it does not explicitly specify sterility requirements. Hospitals must follow their own infection control protocols to ensure safe reuse if applicable. Since it is an external device, sterility is less critical than with implanted devices, but proper cleaning and maintenance are essential for reusable units.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The Model EC4542G was cleared through the traditional 510(k) pathway under FDA clearance number K896352, with a decision of *Substantially Equivalent* (SESE). It is classified as a Class II device under 21 CFR 870.3600, which governs external pulse-generator pacemakers. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee in 1990.

• Are there any special storage conditions or MRI safety considerations mentioned for this device?

  The provided regulatory data does not specify any special storage conditions or MRI safety information for the Model EC4542G. Users should follow general hospital protocols for electrical medical devices, ensuring proper handling and storage to maintain functionality. Since it is an external device, MRI safety is not a primary concern unless the patient requires imaging while using it.