Pulse Generator 678 B

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

510(k) Number

K820657 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Servo Gas Monitor 120

  Class II

  FDA 510(k) K861625 Active Cleared 2 May 1986

• Master Program Flow & Pressure CO2 & Lung Monitor

  Class II

  FDA 510(k) K861707 Active Cleared 19 Jun 1986

• Siemens-Elema Pulse Generator 625

  Class III

  FDA 510(k) K801508 Active Cleared 16 Sep 1980

• Endocardial Leads 414S & 515S

  Class III

  FDA 510(k) K802816 Active Cleared 16 Jan 1981

• Gas Supply Manifold Siemens-Elema Ab

  Class I

  FDA 510(k) K840326 Active Cleared 7 Jun 1984

• Pacemaker Sys. Analyzer 378

  Class II

  FDA 510(k) K832959 Active Cleared 14 Nov 1983

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• Is this pulse generator designed for single-use or can it be reused in multiple patients?

  The Pulse Generator 678 B is supplied as a reusable medical instrument, meaning it is intended for repeated use across different patients. Since it is not described as single-use or sterile, it should be handled according to standard reprocessing protocols for reusable implantable devices.

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

  This device received FDA clearance through a 510(k) Traditional pathway with a decision classification of Substantially Equivalent (SESE). This means the manufacturer demonstrated that the Pulse Generator 678 B is at least as safe and effective as a legally marketed device that was not subject to premarket approval (PMA). The classification under product code DXY and Cardiovascular specialty further confirms its regulatory oversight as a high-risk, life-sustaining device.

• Are there any specific storage requirements mentioned for this pulse generator?

  The available data does not specify any particular storage conditions (e.g., temperature, humidity) or sterility requirements for the Pulse Generator 678 B. Since it is described as non-sterile and reusable, it should be stored in a clean, dry environment following standard medical device reprocessing guidelines to maintain functionality and safety before reuse.

• What is the primary clinical purpose of this pulse generator, and how does it function?

  The Pulse Generator 678 B is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is intended for patients requiring pacing support, ensuring consistent and regulated heart contractions to maintain proper cardiac function—critical for those with bradycardia or other rhythm disorders.