Cleared Traditional

K915799 - BIVONA SLEEP APNEA TUBE

K915799 is an FDA 510(k) clearance for BIVONA SLEEP APNEA 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 41-day FDA review.

K915799 · Bivona Medical Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K915799

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
Combination Product No
PCCP Authorized No
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.

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 K915799.
MECONIUM SUCTION DEVICE (MSD)
K914370 · Vital Signs, Inc. · Jan 1993
ENDOTRACHEAL CPAP SET
K915277 · Vital Signs, Inc. · Mar 1992
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
K920900 · Polamedco, Inc. · Mar 1992
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
K912290 · Boston Medical Products, Inc. · Aug 1991
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · Boston Medical Products, Inc. · Feb 1991
CUFFED LINDER NASOTRACHEAL AIRWAY
K900457 · Polamedco, Inc. · Apr 1990