Pacemaker, Model 252, C-MOS

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780437 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  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

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  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 purpose of the Pacemaker, Model 252, C-MOS, and who is it designed for?

  The Pacemaker, Model 252, C-MOS is designed to regulate heart rhythm by delivering electrical impulses to the heart when needed. It is intended for patients with bradycardia or other conduction disorders that require artificial pacing to maintain proper cardiac function.

• Is this device intended for single-use or reusable implantation, and how should it be handled?

  This device is supplied sterile and intended for single-use implantation only. Since it is classified as an implantable device, storage and handling must strictly follow sterile implantable device protocols to ensure patient safety.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Pacemaker, Model 252, C-MOS received FDA 510(k) clearance (K780437) through a traditional review process, determined to be substantially equivalent to predicate devices. This means it was evaluated by the FDA’s Cardiovascular Advisory Committee in 1978 and deemed compliant with existing safety and performance standards for implantable pacemakers.

• How is this device classified, and what does that classification imply for its use in clinical settings?

  This device is classified as a Class III medical device under the FDA’s regulatory framework, which applies to high-risk devices requiring strict pre-market approval or clearance. As an implantable pacemaker, it falls under 21 CFR 870.3610 and is intended for critical cardiac rhythm management, requiring careful clinical assessment before implantation.