Cleared Traditional

K931749 - BIVONA(R) ICU ENDOTRACHEAL TUBE

K931749 is an FDA 510(k) clearance for BIVONA ICU ENDOTRACHEAL TUBE, manufactured by Bivona Medical Technologies. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K931749 · Bivona Medical Technologies · Anesthesiology device
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Aug 1993
Decision
124d
Days
Class 2
Risk

K931749 is an FDA 510(k) clearance for the BIVONA(R) ICU ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 - K931749

510(k) Number K931749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date August 10, 1993
Days to Decision 124 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 140d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 154
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K931749.
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K925505 · Rusch, Inc. · Sep 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
K925507 · Rusch, Inc. · Sep 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP
K925508 · Rusch, Inc. · Sep 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K925506 · Rusch, Inc. · Aug 1993
PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
K932711 · Precision Med Products, Ltd. · Jul 1993
GUEDEL AIRWAYS
K932561 · Life Shield Healthcare Products, Inc. · Jul 1993