Cleared Traditional

K852632 - GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB (FDA 510(k) Clearance)

Class I Anesthesiology device.

K852632 · Medicomp, Inc. · Anesthesiology device
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Jan 1986
Decision
197d
Days
Class 1
Risk

K852632 is an FDA 510(k) clearance for the GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Medicomp, Inc. (Anoka, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 197 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Medicomp, Inc. devices

Submission Details

510(k) Number K852632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date January 03, 1986
Days to Decision 197 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 139d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.