Cleared Traditional

K942395 - ENDOTRACHEAL TUBE HOLDER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K942395 · S.T.I. Medical Products Corp. · Anesthesiology device
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Jun 1994
Decision
42d
Days
Class 1
Risk

K942395 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE HOLDER. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by S.T.I. Medical Products Corp. (Newport Beach, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 S.T.I. Medical Products Corp. devices

Submission Details

510(k) Number K942395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date June 30, 1994
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 139d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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.