510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910381Substantially Equivalent

Biochem Temperature/ Fio2 Module

Biochem International, Inc., Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910381 is the FDA 510(k) clearance record for BIOCHEM TEMPERATURE/ FIO2 MODULE, a class II device, cleared for Biochem International, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 28 510(k) clearances for Biochem International, Inc., from to . As of , FDA records show no recalls naming K910381.

Clearance record

Decision date
Received
(205 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Biochem International, Inc. W238 N1650 Rockwood Dr., Waukesha WI
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260