510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072621Substantially Equivalent

Esophageal/rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor

Gentherm Medical, LLC, Sharonville OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072621 is the FDA 510(k) clearance record for ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, a class II device, cleared for Cincinnati Sub-Zero Products, Inc. on under FDA product code BZT (Stethoscope, Esophageal, With Electrical Conductors). FDA records list 12 510(k) clearances for Gentherm Medical, LLC, from to . As of , FDA records show one recall naming K072621.

Clearance record

Decision date
Received
(87 days to decision)
Product code
BZT Stethoscope, Esophageal, With Electrical Conductors
Regulation
21 CFR 868.1920
Device class
Class II
Review panel
Anesthesiology
Applicant
Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Rd., Sharonville OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZT

Trailing 12 months
1 clearance under product code BZT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260