Cleared Traditional

K891124 - NON-REBREATHING AIRWAY AND MASK(S) KITS (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K891124 · Airway Products, Inc. · Anesthesiology device
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Oct 1989
Decision
224d
Days
Class 2
Risk

K891124 is an FDA 510(k) clearance for the NON-REBREATHING AIRWAY AND MASK(S) KITS. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Airway Products, Inc. (Blue Springs, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 224 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Airway Products, Inc. devices

Submission Details

510(k) Number K891124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date October 13, 1989
Days to Decision 224 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 139d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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.