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Unifocal 2-UNIPOLAR & Bipolar

by American Pacemaker Corp.

510(k) K792199

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 NumberK792199 Date27 Nov 1979ClearedStatusActive

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  • Withdrawn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 Unifocal 2-Unipolar & Bipolar is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It combines unipolar and bipolar pacing configurations, enabling flexible pacing modes for patients requiring temporary or permanent cardiac stimulation.

This device is intended for implantable use within the cardiovascular system and has received FDA 510(k) clearance (K792199) under the Substantially Equivalent (SESE) determination. Regulated under 21 CFR 870.3610, it is classified as a high-risk, life-sustaining device and is supplied as a reusable implantable component. No additional sterility or MRI safety specifications are noted in the available data.

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