Cleared Traditional

K905052 - BIVONA ENDOTRACHEAL TUBE STYLET

K905052 is an FDA 510(k) clearance for BIVONA ENDOTRACHEAL TUBE STYLET, manufactured by Bivona Medical Technologies. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K905052 · Bivona Medical Technologies · Anesthesiology device
Download Printable Device Report (PDF)
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Apr 1991
Decision
145d
Days
Class 1
Risk

K905052 is an FDA 510(k) clearance for the BIVONA ENDOTRACHEAL TUBE STYLET. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 145 days - within the typical 510(k) review window.

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 Bivona Medical Technologies devices

FDA 510(k) Submission Details - K905052

510(k) Number K905052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date April 02, 1991
Days to Decision 145 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
5d slower than avg
Panel avg: 140d · This submission: 145d
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 14
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K905052.
AUGUSTINE GUIDE(TM) KIT
K912690 · Augustine Medical, Inc. · Sep 1991
AUGUSTINE STYLET
K910659 · Augustine Medical, Inc. · May 1991
STYLET TRACHAEL TUBE
K905133 · Medical Devices, Inc. · Apr 1991
N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE
K865108 · Ackrad Laboratories · Feb 1987
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE
K844557 · Ackrad Laboratories · Dec 1984
TUBE-STAT
K843490 · Concept, Inc. · Oct 1984