Cleared Traditional

K905133 - STYLET TRACHAEL TUBE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K905133 · Medical Devices, Inc. · Anesthesiology device
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Apr 1991
Decision
158d
Days
Class 1
Risk

K905133 is an FDA 510(k) clearance for the STYLET TRACHAEL TUBE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Medical Devices, Inc. (Lakewood, US). The FDA issued a Cleared decision on April 22, 1991 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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 Medical Devices, Inc. devices

Submission Details

510(k) Number K905133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date April 22, 1991
Days to Decision 158 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 139d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
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.