Cleared Traditional

K934288 - HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K934288 · Neo-Tech, Inc. · Anesthesiology device
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Jun 1994
Decision
280d
Days
Class 1
Risk

K934288 is an FDA 510(k) clearance for the HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Neo-Tech, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 9, 1994 after a review of 280 days - an extended review 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: 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 Neo-Tech, Inc. devices

Submission Details

510(k) Number K934288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1993
Decision Date June 09, 1994
Days to Decision 280 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
141d slower than avg
Panel avg: 139d · This submission: 280d
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.