Cleared Traditional

K892854 - ANESTHETIC AGENT MONITOR

K892854 is an FDA 510(k) clearance for ANESTHETIC AGENT MONITOR, manufactured by Criticare Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K892854 · Criticare Systems, Inc. · Anesthesiology device
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Oct 1989
Decision
178d
Days
Class 2
Risk

K892854 is an FDA 510(k) clearance for the ANESTHETIC AGENT MONITOR. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 178 days - an extended review cycle.

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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K892854

510(k) Number K892854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date October 13, 1989
Days to Decision 178 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
38d slower than avg
Panel avg: 140d · This submission: 178d
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 15
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