Cleared Traditional

K884427 - FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRW...

K884427 is the FDA 510(k) clearance for FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRW... by Bivona Medical Technologies. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K884427 · Bivona Medical Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
13d
Days
Class 2
Risk

K884427 is an FDA 510(k) clearance for the FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.. 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 November 2, 1988 after a review of 13 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

Submission Details

510(k) Number K884427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date November 02, 1988
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K884427.
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
SHILEY PHONATION VALVE
K900548 · Shiley, Inc. · Apr 1990
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · Shiley, Inc. · Jan 1989
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614 · Shiley, Inc. · Mar 1988
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247 · Shiley, Inc. · Feb 1988
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · Cook, Inc. · May 1987