Cleared Traditional

K862267 - FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES

K862267 is an FDA 510(k) clearance for FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES, manufactured by Bivona Medical Technologies. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K862267 · Bivona Medical Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
5d
Days
Class 2
Risk

K862267 is an FDA 510(k) clearance for the FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on June 18, 1986 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 - K862267

510(k) Number K862267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date June 18, 1986
Days to Decision 5 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
135d faster than avg
Panel avg: 140d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 58
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K862267.
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · Cook, Inc. · May 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · Shiley, Inc. · Jan 1987
MINI-TRACH KIT
K862167 · Portex, Inc. · Aug 1986
TRACHEOSTOMY CARE KIT
K855130 · Dynarex Corp. · Mar 1986
LARYNGECTOMY TUBE, CUFFED
K860176 · Sheridan Catheter Corp. · Jan 1986
THE HOOD LIFE SAVER
K853511 · Hood Laboratories · Dec 1985