Skip to content

Dispos Access External Cardiac Pacemaker

by Keller Medical Specialties Products, Inc.

510(k) K903437

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 NumberK903437 Date16 Nov 1990ClearedStatusActive

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  • Withdrawn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
DRO
Device Class
Class II
Regulation
21 CFR Part 870.5550
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This device is an external transcutaneous (non-invasive) cardiac pacemaker. It is designed for temporary cardiac pacing through the skin without surgical implantation.

It is supplied as a disposable, single-use device. The device received FDA 510(k) clearance (K903437) on November 16, 1990, and is classified as a Class II medical device under regulation number 870.5550.

Other devices from Keller Medical Specialties Products, Inc.

Questions

AI-generated answers, 23 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 DISPOS ACCESS External Cardiac Pacemaker used for?

    It is designed for temporary cardiac pacing through the skin without surgical implantation, providing non-invasive transcutaneous pacing for short-term support.

  • Is the DISPOS ACCESS External Cardiac Pacemaker reusable or single-use?

    It is supplied as a disposable, single-use device, meaning it is intended for one patient and one procedure only, then discarded to prevent cross-contamination.

  • How is the DISPOS ACCESS External Cardiac Pacemaker supplied?

    The device is supplied as a sterile, disposable unit for single-use application, packaged ready for immediate clinical use in temporary pacing scenarios.

  • What regulatory pathway was used for the DISPOS ACCESS External Cardiac Pacemaker?

    It received FDA 510(k) clearance under K903437 on November 16, 1990, demonstrating substantial equivalence to a legally marketed predicate device.