Cleared Traditional

K910381 - BIOCHEM TEMPERATURE/ FIO2 MODULE

K910381 is an FDA 510(k) clearance for BIOCHEM TEMPERATURE/ FIO2 MODULE, manufactured by Biochem International, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K910381 · Biochem International, Inc. · Anesthesiology device
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Aug 1991
Decision
205d
Days
Class 2
Risk

K910381 is an FDA 510(k) clearance for the BIOCHEM TEMPERATURE/ FIO2 MODULE. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Biochem International, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 22, 1991 after a review of 205 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biochem International, Inc. devices

FDA 510(k) Submission Details - K910381

510(k) Number K910381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date August 22, 1991
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 49
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