Cleared Traditional

K771587 - INSTANT AIR (FDA 510(k) Clearance)

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

K771587 · Hyde, Vernon E., D.D.S. · Anesthesiology device
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Sep 1977
Decision
15d
Days
Class 2
Risk

K771587 is an FDA 510(k) clearance for the INSTANT AIR. Classified as Needle, Emergency Airway (product code BWC), Class II - Special Controls.

Submitted by Hyde, Vernon E., D.D.S. (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hyde, Vernon E., D.D.S. devices

Submission Details

510(k) Number K771587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1977
Decision Date September 02, 1977
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 139d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.