Pulse Generator 686, 686B, 686L

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

510(k) Number

K841230 ↗

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

See all devices from Siemens Elema AB →

• What is the primary purpose of the Pulse Generator 686, 686B, and 686L, and how does it function in a patient’s body?

  The Pulse Generator 686, 686B, and 686L are designed to regulate cardiac rhythm by delivering electrical impulses to the heart. They are intended for patients with bradycardia or conduction disorders, providing consistent pacing stimulation to maintain proper heart function. Implanted subcutaneously in the chest, these devices require surgical placement and external programming adjustments to optimize pacing parameters.

• Are these devices single-use or reusable, and what does that mean for their maintenance and replacement?

  These pulse generators are reusable, meaning they are designed for long-term implantation and can remain in place for extended periods. However, they may require periodic replacement due to battery depletion or other factors, and maintenance involves external programming adjustments rather than device replacement for routine use.

• What special considerations should be taken into account when handling or storing these devices?

  Sterility is critical when handling these devices, as they are implanted surgically. Additionally, they are not MRI-compatible, so patients must avoid MRI scans to prevent potential damage or interference. Storage should follow manufacturer guidelines to preserve functionality and sterility.

• How were these devices approved by the FDA, and what does that mean for their use in clinical settings?

  The Pulse Generator 686, 686B, and 686L received FDA clearance through a 510(k) submission (K841230), which means they were determined to be substantially equivalent to a legally marketed device already on the market. This approval route ensures they meet regulatory standards for cardiovascular devices, allowing their use in clinical settings for patients requiring pacemaker therapy.