Cleared Traditional

K892646 - BIOCHEM 8100 ANESTHETIC AGENT MONITOR

K892646 is the FDA 510(k) clearance for BIOCHEM 8100 ANESTHETIC AGENT MONITOR by Biochem International, Inc.. It is a Class 2 Anesthesiology device (product code CBQ) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K892646 · Biochem International, Inc. · Anesthesiology device
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Aug 1989
Decision
141d
Days
Class 2
Risk

K892646 is an FDA 510(k) clearance for the BIOCHEM 8100 ANESTHETIC AGENT MONITOR. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Biochem International, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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

Submission Details

510(k) Number K892646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1989
Decision Date August 31, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
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 - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

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