Cleared Traditional

BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER (K884927) - FDA 510(k) Clearance

Class I Anesthesiology device.

K884927 · Instrumentation Industries, Inc. · Anesthesiology device
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Jun 1989
Decision
207d
Days
Class 1
Risk

K884927 is an FDA 510(k) clearance for the BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 207 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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 Instrumentation Industries, Inc. devices

Submission Details

510(k) Number K884927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date June 23, 1989
Days to Decision 207 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 139d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.