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ALLON 2001

by Mtre Advanced Technology, Ltd.

510(k) K001546

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 · Special NumberK001546 Date8 Jun 2000ClearedStatusActive

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  • Withdrawn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
DWJ
FDA applicant
Mtre Advanced Technology , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 ALLON 2001 is a thermal regulating system classified as a Class II medical device under FDA regulation number 870.5900. It is substantially equivalent to a predicate device and received special 510(k) clearance (K001546) on June 8, 2000, from Mtre Advanced Technology, Ltd.

The device is intended for cardiovascular applications and is identified by product code DWJ. It is manufactured by Mtre Advanced Technology, Ltd., located in Mccordsville, Indiana, and is registered under multiple FDA establishment identifiers and registration numbers as specified in the device data.

Other devices from Mtre Advanced Technology, Ltd.

  • Allon 2001 Version 5 Open recall

    Class II

  • Allon 2000

    Class II

  • Criticool Open recall

    Class II

  • Criticool Pro

    Class II

  • Allon 2001 Modified

    Class II

Questions

AI-generated answers, 22 Sep 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 ALLON 2001 used for?

    The ALLON 2001 is intended for cardiovascular applications as a thermal regulating system, as indicated by its product code DWJ and classification under FDA regulation number 870.5900 for cardiovascular devices.

  • How was the ALLON 2001 cleared for market?

    The ALLON 2001 received special 510(k) clearance (K001546) on June 8, 2000, demonstrating substantial equivalence to a predicate device under FDA regulation 870.5900.

  • Who manufactures the ALLON 2001 and where is it located?

    The ALLON 2001 is manufactured by Mtre Advanced Technology, Ltd., located at 6329 W. Waterview Ct., Mccordsville, Indiana, 46055, United States.