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Hemotherm Model 400

by Cincinnati Sub-Zero

510(k) K811742

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK811742 Date13 Aug 1981ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2720-2011 FDA Unclassified (pre-2012) initiated 2 May 2011
    • Terminated Z-2721-2011 FDA Unclassified (pre-2012) initiated 2 May 2011

    The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Cincinnati Sub-Zero

  • Maxitherm

    Class II