Pacemaker, Model 225 & 227

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K772226 ↗

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 225 & 227, and how does it function in the body?

  The Pacemaker, Model 225 & 227, is designed to regulate abnormal heart rhythms by delivering controlled electrical impulses to the heart muscle. This helps maintain a consistent heartbeat when the heart’s natural pacemaker fails to do so, ensuring proper cardiac function for patients with life-threatening arrhythmias.

• Is this device intended for single-use or can it be reused after implantation?

  This device is supplied sterile and explicitly intended for single-use only. It is not designed for reuse, as its sterile packaging ensures patient safety during implantation.

• What regulatory pathway was followed for FDA clearance of this pacemaker, and which committee reviewed it?

  The Pacemaker, Model 225 & 227, underwent a Traditional review pathway under the FDA’s 510(k) clearance process, with the Cardiovascular (CV) Advisory Committee overseeing its evaluation. The clearance number is K772226, and it aligns with FDA regulation 870.3610 for implantable pacemakers.

• Are there different models or sizes available for this pacemaker, and how would a clinician determine the appropriate fit?

  The device is listed as two models, 225 and 227, but the specifications do not detail size variations. Selection would depend on clinical assessment, patient anatomy, and compatibility with the implanted leads, typically guided by the manufacturer’s guidelines and the surgeon’s expertise.