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Norm-O-Temp Hyperthermia System Incliding Blankets/Pads

by Cincinnati Sub-Zero Products, Inc.

510(k) K120081

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK120081 Date17 Feb 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2355-2019 FDA Class II initiated 20 Jun 2019

    The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

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  • Withdrawn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

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