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Pulstron Model 100

by Micro-Rel

510(k) K781835

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781835 Date21 Dec 1978ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pulstron Model 100 is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It falls under the classification of an implantable cardiac device, specifically categorized as an Implantable Pacemaker Pulse-Generator according to regulatory nomenclature.

This device is intended for surgical implantation and is classified as a Class III medical device under FDA regulations. It is supplied sterile and intended for single-use implantation, with no indication of MRI compatibility in the specifications. The device is authorized under FDA 510(k) clearance (K781835) and adheres to regulatory requirements outlined in 21 CFR 870.3610 for pacemaker pulse-generators.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Pulstron Model 100 and how does it function in the body?

    The Pulstron Model 100 is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is surgically implanted to help manage abnormal heartbeats, ensuring the heart contracts at a consistent and appropriate rate when the natural pacemaker (sinoatrial node) fails to do so.

  • Is the Pulstron Model 100 intended for reuse or is it a single-use device?

    The Pulstron Model 100 is explicitly intended for single-use implantation. Once implanted, it is not designed to be removed or reused, aligning with standard practices for implantable cardiac devices to ensure patient safety and sterility.

  • How is the Pulstron Model 100 supplied, and what does that mean for handling before implantation?

    The Pulstron Model 100 is supplied sterile, meaning it is pre-packaged and prepared for direct use in a sterile surgical environment. This ensures it is free from contamination before implantation, reducing infection risks during surgery.

  • What regulatory pathway was followed for the Pulstron Model 100, and which committee reviewed its submission?

    The Pulstron Model 100 was authorized through the FDA’s 510(k) clearance process, specifically under the Traditional pathway. Its submission was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates the safety and effectiveness of cardiovascular devices like pacemakers.

  • Are there any specific storage requirements mentioned for the Pulstron Model 100 before use?

    The provided data does not specify detailed storage requirements, but as a sterile, single-use implantable device, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Always follow manufacturer guidelines for optimal preservation.