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TEMPO III

by Medical Products, Inc.

510(k) K981509

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 NumberK981509 Date10 Jul 1998ClearedStatusActive

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  • Withdrawn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
LGZ
Device class
Class II
Regulation
21 CFR Part 880.5725
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 TEMPO III is a Warmer, Thermal, Infusion Fluid device classified as a General Hospital device under product code LGZ. It is designed to store and warm I.V. fluid bags or bottles prior to their use.

The device is supplied as a reusable unit for use in general hospital settings. It received FDA 510(k) clearance (K981509) on July 10, 1998, under regulation 880.5725, and is classified as a Class II medical device.

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