Cleared Traditional

K911263 - 22MM ID/OD ADAPTER

K911263 is an FDA 510(k) clearance for 22MM ID/OD ADAPTER, manufactured by Monaghan Medical Corp.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K911263 · Monaghan Medical Corp. · Anesthesiology device
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Aug 1991
Decision
150d
Days
Class 1
Risk

K911263 is an FDA 510(k) clearance for the 22MM ID/OD ADAPTER. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on August 19, 1991 after a review of 150 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K911263

510(k) Number K911263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1991
Decision Date August 19, 1991
Days to Decision 150 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
10d slower than avg
Panel avg: 140d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 53
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K911263.
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