Models 253-19 & 254-20 Quantum Generators

No FDA recalls on record, checked 22 Oct 2026.

Full name

Modified Models 253-19 & 254-20 Quantum Generators

510(k) Number

K873528 ↗

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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  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

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  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 pulse-generators designed for use in patients with specific heart conditions, and if so, which ones?

  These devices, the Models 253-19 & 254-20 Quantum Generators, are intended for patients with bradycardia or conduction disorders where the heart’s natural electrical system fails to maintain adequate cardiac output. They deliver programmable pacing impulses to regulate heart rhythm, either when implanted subcutaneously or intrathoracically.

• How are these pulse-generators supplied, and what precautions should be taken during handling?

  The pulse-generators are supplied as sterile, single-use devices, meaning each unit is intended for one surgical implantation only. Handling must follow sterile medical device protocols to ensure no contamination occurs before use, as they are not designed for reuse.

• Are there different models available, and if so, how do they differ?

  Yes, there are two models listed: the 253-19 and the 254-20. While the exact technical differences between them are not specified in the regulatory data, both are classified as Implantable Pacemaker Pulse-Generators and are intended for the same clinical purpose—regulating heart rhythm in patients with bradycardia or conduction disorders.

• What regulatory pathway was used for FDA clearance, and what does that mean for their use?

  These devices were cleared via the Traditional 510(k) pathway and were determined to be Substantially Equivalent to a predicate device. This means the FDA reviewed them against an existing, legally marketed device to ensure they have the same intended use and safety profile, allowing them to be legally marketed in the U.S. without additional clinical trials.

• Do these pulse-generators have any known compatibility restrictions, such as with MRI environments?

  The regulatory data does not specify compatibility with MRI environments, so users should consult the manufacturer’s instructions or technical documentation for guidance on safe use in such settings. Always verify compatibility before exposing the device to MRI scans.