Cleared Traditional

K905133 - STYLET TRACHAEL TUBE

K905133 is an FDA 510(k) clearance for STYLET TRACHAEL TUBE, manufactured by Medical Devices, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 158-day FDA review.

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

FDA 510(k) Submission Details - K905133

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

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.

Regulatory Peers - BSR Stylet, Tracheal Tube

All 8
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