Pulse Generator 688B & 688L

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

510(k) Number

K841231 ↗

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 II

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  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

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• 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

See all devices from Siemens Elema AB →

• What is the primary clinical purpose of the Pulse Generator 688B & 688L, and how does it function in patients?

  The Pulse Generator 688B & 688L is designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders by generating timed electrical impulses. It delivers these stimuli to the heart through implanted leads, ensuring consistent pacing to maintain proper heart function. This makes it essential for patients requiring life-sustaining cardiac support.

• Is the Pulse Generator 688B & 688L intended for single-use or reusable applications, and what does this mean for surgical planning?

  The device is explicitly intended for single-use implantation only, meaning it is not designed to be removed, cleaned, or reused. This requires surgical planning to account for a new device during implantation, as it must remain sterile and intact until use. Sterile surgical protocols must be followed during handling and implantation.

• How should the Pulse Generator 688B & 688L be stored, and what precautions must be taken to maintain its integrity?

  Since the device is supplied sterile and intended for surgical implantation, it must be stored according to sterile surgical protocols. This includes keeping it in its original packaging, protecting it from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity) to ensure sterility and functionality before use.

• Does the Pulse Generator 688B & 688L have any specific compatibility considerations, such as MRI safety?

  Yes, the device adheres to MRI safety standards for Class III devices, meaning it is designed to be compatible with MRI environments under specific conditions. However, exact MRI compatibility details (e.g., safe scanning parameters) should be verified with the manufacturer’s documentation, as improper exposure could affect performance or patient safety.

• What regulatory pathway was used for FDA clearance of the Pulse Generator 688B & 688L, and what does this imply for its risk classification?

  The device was cleared under the Premarket Approval (PMA) pathway (product code DXY) and classified as a Class III high-risk, life-sustaining device by the FDA. This pathway is reserved for devices that support or sustain human life and pose significant risks if they fail, reflecting its critical role in cardiovascular function and the rigorous evaluation it underwent.