Cleared Traditional

K912469 - BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE

K912469 is an FDA 510(k) clearance for BIVONA WIRE REINFORCED PEDIATRIC TRACHE..., 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 15-day FDA review.

K912469 · Bivona Medical Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
15d
Days
Class 2
Risk

K912469 is an FDA 510(k) clearance for the BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE. 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 19, 1991 after a review of 15 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 - K912469

510(k) Number K912469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1991
Decision Date June 19, 1991
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
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 K912469.
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992
BIVONA TRACHEAL T-TUBE STENT
K920604 · Bivona Medical Technologies · Jul 1992
TRACHEOSTOMY TUBE AND CUFF
K912124 · Concord/Portex · Aug 1991
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K903730 · Concord/Portex · Sep 1990
SHILEY PHONATION VALVE
K900548 · Shiley, Inc. · Apr 1990
TRACHEOSTOMY TRAY
K896798 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990