Cleared Traditional

K915799 - BIVONA SLEEP APNEA TUBE

K915799 is the FDA 510(k) clearance for BIVONA SLEEP APNEA TUBE by Bivona Medical Technologies. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K915799 · Bivona Medical Technologies · Anesthesiology device
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Feb 1992
Decision
41d
Days
Class 2
Risk

K915799 is an FDA 510(k) clearance for the BIVONA SLEEP APNEA 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 February 3, 1992 after a review of 41 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bivona Medical Technologies devices

Submission Details

510(k) Number K915799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date February 03, 1992
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 60
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K915799.
GENERAL ANESTHESIA SYSTEM
K945455 · Vital Signs, Inc. · Dec 1994
MECONIUM SUCTION DEVICE (MSD)
K914370 · Vital Signs, Inc. · Jan 1993
ENDOTRACHEAL CPAP SET
K915277 · Vital Signs, Inc. · Mar 1992
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · Mallinckrodt Critical Care · Nov 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · Mallinckrodt Critical Care · Apr 1987
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · Mallinckrodt Critical Care · Aug 1986