Cleared Traditional

K892646 - BIOCHEM 8100 ANESTHETIC AGENT MONITOR

K892646 is an FDA 510(k) clearance for BIOCHEM 8100 ANESTHETIC AGENT MONITOR, manufactured by Biochem International, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K892646

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
Combination Product No
PCCP Authorized No
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.

CBQ Device Classification - Class 2, Special Controls

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)

All 16
Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K892646.
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