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Optima MPT Model 5281E and Model 5282E

by Telectronics Pacing Systems, Inc.

510(k) K897116

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 NumberK897116 Date14 Mar 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  • Withdrawn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
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 Model 5281E and Model 5282E are implantable pacemaker pulse-generators designed to regulate heart rhythm by delivering electrical impulses. These devices are classified as Class III medical devices under FDA regulations, intended for patients requiring cardiac pacing support.

These devices are supplied sterile and intended for single-use implantation by qualified healthcare professionals. They are regulated under FDA 510(k) clearance (K897116) and comply with regulation number 870.3610. The pulse-generators are available in two models, 5281E and 5282E, and are intended for use in cardiovascular settings, with no specific MRI safety labeling indicated.

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