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Maxone IV Fluid/Blood Warmer, Model 102

by Automatic Medical Technologies, Inc.

510(k) K023653

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 NumberK023653 Date17 Jan 2003ClearedStatusActive

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  • Withdrawn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, 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 Maxone IV Fluid/Blood Warmer, Model 102 is a thermal infusion fluid warmer designed to warm blood products and intravenous solutions prior to administration. It is indicated for use in hospital, clinical, and field environments by healthcare professionals.

The device consists of a reusable heating unit with controller and an on/off switch, designed to be used with disposable Maxone warmer cartridges. It is placed in-line between a standard IV drip set and a standard IV extension set, and is designed to warm blood, blood products, and intravenous liquids at flow rates of up to and including 150 mL/min. It received FDA 510(k) clearance under K023653 and is classified as a Class II device under regulation number 880.5725.

Other devices from Automatic Medical Technologies, Inc.

Questions

AI-generated answers, 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.

  • What is the Maxone IV Fluid/Blood Warmer Model 102 used for?

    It is designed to warm blood products and intravenous solutions prior to administration in hospital, clinical, and field environments by healthcare professionals.

  • How is the Maxone IV Fluid/Blood Warmer Model 102 supplied and used?

    It consists of a reusable heating unit with controller and on/off switch, used with disposable Maxone warmer cartridges placed in-line between a standard IV drip set and extension set.

  • What is the maximum flow rate supported by the Maxone IV Fluid/Blood Warmer Model 102?

    It is designed to warm blood, blood products, and intravenous liquids at flow rates of up to and including 150 mL/min.