Quantum Models 253-09, 254-09, 254-10

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K820853 ↗

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. →

• Are these pacemakers designed for single-use or can they be reused after implantation?

  These Quantum Models (253-09, 254-09, 254-10) are explicitly labeled as reusable medical devices, meaning they are intended for surgical implantation by qualified professionals and can be reused after proper cleaning, sterilization, and maintenance. Since they are implantable pulse-generators, they are not disposable but rather designed for long-term cardiac support.

• What specific cardiac conditions are these pacemakers intended to address?

  The Quantum Models are designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring artificial pacing to manage bradycardia (slow heart rate) or other conduction disorders. They ensure consistent and reliable cardiac function in patients who depend on pacing therapy.

• How are these devices supplied, and what should clinicians consider when handling them?

  These devices are supplied as reusable implantable pacemaker pulse-generators, meaning they are intended for surgical implantation by trained healthcare professionals. While the data does not specify sterility or MRI safety details, clinicians should follow standard protocols for handling implantable devices, including proper storage, sterilization (if reused), and adherence to manufacturer guidelines for surgical implantation.

• What regulatory pathway was followed for these devices, and what does that mean for their use?

  The Quantum Models were cleared under FDA 510(k) K820853 in April 1982, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. As Class III devices, they are classified as high-risk, life-sustaining, and require premarket approval. This means they undergo rigorous review to ensure safety and effectiveness for managing bradycardia or conduction disorders in patients requiring artificial pacing.