Model 4220 Implantable Pacemaker Pulse-Generator

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Model 4220

510(k) Number

K913134 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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

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• What is the primary clinical purpose of the Model 4220 pacemaker, and who should consider it for use?

  The Model 4220 is designed to regulate heart rhythm by delivering electrical impulses to treat bradycardia or other cardiac conduction disorders requiring chronic pacing support. It is intended for patients who need programmable pacing rates and modes to maintain stable cardiac function, typically those with slow heart rates or conduction abnormalities that affect their heart’s ability to pump blood effectively.

• Is the Model 4220 meant for reuse, or is it intended for single-use implantation only?

  The Model 4220 is explicitly supplied sterile and intended for single-use implantation by a qualified healthcare professional. It is not designed for reuse, and proper handling per manufacturer guidelines ensures patient safety and device functionality.

• How is the Model 4220 regulated by the FDA, and what does its classification mean for clinical use?

  The Model 4220 is classified as a Class III medical device under FDA regulation 870.3610 and holds a Traditional 510(k) clearance with a decision date of August 22, 1991. This classification reflects its role in life-sustaining or supporting functions, requiring rigorous pre-market review to ensure safety and effectiveness. The clearance indicates it is deemed substantially equivalent to a predicate device, meeting FDA standards for implantable pacemaker pulse-generators.

• Can the Model 4220 be used in an MRI environment, and what precautions should be taken?

  The Model 4220 is MRI-unsafe, meaning it should never be exposed to MRI environments due to potential risks of malfunction or injury. Strict adherence to manufacturer guidelines is required to ensure proper function and patient safety, including avoiding MRI scans entirely for patients with this device implanted.

• What does the product code (DXY) and advisory committee (CV) indicate about the regulatory pathway for this device?

  The product code DXY categorizes the Model 4220 under the FDA’s Implantable Pacemaker Pulse-Generator classification, while the advisory committee (CV) designation refers to its review by the Cardiovascular Panel during the 510(k) clearance process. This panel evaluates cardiovascular devices to ensure they meet safety and performance standards before approval, though the final decision rests with the FDA.