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Optima Mpt Series III Pacemaker, 5281D and 5282D

by Telectronics, Inc.

510(k) K881837

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 NumberK881837 Date18 Jul 1988ClearedStatusActive

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  • Withdrawn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 Optima MPT Series III Pacemaker, Models 5281D and 5282D, is an implantable pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. This device is classified as an Implantable Pacemaker Pulse-Generator and is intended for patients requiring cardiac pacing to treat bradycardia or other conduction disorders.

These pacemakers are intended for surgical implantation and are supplied sterile for single-use. They are regulated under FDA 510(k) clearance (K881837) and fall under device classification DXY, adhering to regulation 870.3610. The devices are manufactured by Telectronics, Inc., and are intended for use in cardiovascular settings, with no indication of MRI safety or reusable components.

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