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Pacemaker Programmer #2010

by Cardiac Pacemakers, Inc.

510(k) K811217

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 NumberK811217 Date20 Jul 1981ClearedStatusActive

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  • Withdrawn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
KRG
Device Class
Class III
Regulation
21 CFR Part 870.3700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Pacemaker Programmer #2010 is a medical device classified as a pacemaker programmer, designed to noninvasively adjust the electrical operating parameters of implanted pacemakers. It enables clinicians to modify pacing rates, output voltages, timing intervals, and other programmable features to optimize cardiac rhythm management. This device is intended for use with compatible pacemaker models, allowing for remote configuration and troubleshooting without direct surgical intervention. Its functionality aligns with the FDA Product Code KRG, which categorizes it under cardiovascular devices for programming implanted cardiac devices.

The Pacemaker Programmer #2010 is supplied as a reusable, non-sterile device intended for use in clinical settings such as hospitals, electrophysiology labs, or cardiac care units. It is regulated under FDA 510(k) clearance (K811217) and falls under Device Class III, reflecting its role in managing life-sustaining or life-supporting functions. The device is not MRI-safe, and its compatibility with specific pacemaker models is determined by the manufacturer’s technical specifications. Storage and handling follow standard medical device protocols to ensure operational integrity, though no additional sterility or single-use requirements are stated in the regulatory data.

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