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Temperature Control & Monitor

by Sams, Inc.

510(k) K841402

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841402 Date11 Jun 1984ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1790-2021 FDA Class II initiated 16 Apr 2021

    Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

    • Terminated Z-1417-2018 FDA Class II initiated 16 Mar 2018

    Update to cooler-heater cleaning instructions.

    • Terminated Z-2208-2016 FDA Class II initiated 8 Jun 2016

    Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

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  • Withdrawn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
DWC
Device Class
Class II
Regulation
21 CFR Part 870.4250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent