Cleared Traditional

K962312 - KEY CHAIN EMERGENCY AIRWAY

K962312 is an FDA 510(k) clearance for KEY CHAIN EMERGENCY AIRWAY, manufactured by Ffrench Pocket Emergency Airway, Inc.. The device is a Class 2 Anesthesiology device with product code BWC cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K962312 · Ffrench Pocket Emergency Airway, Inc. · Anesthesiology device
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Jun 1997
Decision
365d
Days
Class 2
Risk

K962312 is an FDA 510(k) clearance for the KEY CHAIN EMERGENCY AIRWAY. Classified as Needle, Emergency Airway (product code BWC), Class II - Special Controls.

Submitted by Ffrench Pocket Emergency Airway, Inc. (New Orleans, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5090 - 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. Elevated predicate reliance profile. 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 Ffrench Pocket Emergency Airway, Inc. devices

FDA 510(k) Submission Details - K962312

510(k) Number K962312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date June 17, 1997
Days to Decision 365 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 140d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWC Device Classification - Class 2, Special Controls

Product Code BWC Needle, Emergency Airway
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5090
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.