Pacemaker Model 251

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771626 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

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  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of the Pacemaker Model 251, and who should consider using it?

  The Pacemaker Model 251 is designed to regulate abnormal heart rhythms, specifically for patients with bradycardia or other cardiac conduction disorders requiring chronic pacing support. It delivers electrical impulses to the heart muscle to maintain proper heart rate and rhythm. Clinicians should consider this device for patients who have been diagnosed with these conditions and require long-term pacing therapy.

• Is the Pacemaker Model 251 intended for single-use or repeated use, and how should it be handled?

  The Pacemaker Model 251 is supplied as a sterile, single-use implant. It is intended for surgical placement by qualified healthcare professionals only. Handling and storage must follow sterile medical device protocols to ensure safety and efficacy before implantation.

• What regulatory pathway was followed for the FDA clearance of the Pacemaker Model 251, and what classification does it fall under?

  The Pacemaker Model 251 was authorized under the FDA 510(k) clearance process with a determination of *Substantially Equivalent* (SESE) to a predicate device. It is classified as a Class III medical device under regulation number 870.3610 and falls under the cardiovascular specialty category, as reviewed by the Cardiovascular (CV) Advisory Committee.

• How is the Pacemaker Model 251 supplied, and what are the key considerations for storage?

  The device is supplied in a sterile, single-use packaging designed for surgical implantation. Storage must adhere to sterile medical device protocols to preserve its integrity and functionality. Since it is intended for implantation, it should be stored in a clean, controlled environment until use, following manufacturer guidelines to prevent contamination or damage.