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UniPulse

by Seaward Group

510(k) K182905

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182905 Date14 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DRL
Device Class
Class II
Regulation
21 CFR Part 870.5325
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The UniPulse is a defibrillator tester designed to simulate and test defibrillator performance. It is intended for use in evaluating the functionality of defibrillation equipment, ensuring proper operation and safety.

The device is supplied as a single-use, sterile unit and is compatible with monophasic, biphasic, and pulsed waveforms. It features a rechargeable battery for operation without mains power and is regulated under FDA 510(k) clearance (K182905).