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Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor

by Cincinnati Sub-Zero Products, Inc.

510(k) K072621

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 NumberK072621 Date13 Dec 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0372-2012 FDA Unclassified (pre-2012) initiated 26 Sep 2011

    Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.

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  • Withdrawn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
BZT
Device Class
Class II
Regulation
21 CFR Part 868.1920
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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