510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896311Substantially Equivalent

Optex Blood Gas Monitoring System

Optex Biomedical, The Woodlands TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896311 is the FDA 510(k) clearance record for OPTEX BLOOD GAS MONITORING SYSTEM, a class II device, cleared for Optex Biomedical on under FDA product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling). FDA records list one 510(k) clearance for Optex Biomedical. As of , FDA records show no recalls naming K896311.

Clearance record

Decision date
Received
(63 days to decision)
Product code
CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Regulation
21 CFR 868.1200
Device class
Class II
Review panel
Anesthesiology
Applicant
Optex Biomedical 2202 Timberloch Pl.,, The Woodlands TX
Third party review
No

Clearances, product code CCE

Trailing 12 months

FDA records hold no clearances under product code CCE in the trailing twelve months.

FDA records show no clearances under product code CCE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CCE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260