Cleared Traditional

K920604 - BIVONA TRACHEAL T-TUBE STENT

K920604 is an FDA 510(k) clearance for BIVONA TRACHEAL T-TUBE STENT, 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 167-day FDA review.

K920604 · Bivona Medical Technologies · Anesthesiology device
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Jul 1992
Decision
167d
Days
Class 2
Risk

K920604 is an FDA 510(k) clearance for the BIVONA TRACHEAL T-TUBE STENT. 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 July 27, 1992 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K920604

510(k) Number K920604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date July 27, 1992
Days to Decision 167 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
27d slower than avg
Panel avg: 140d · This submission: 167d
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 K920604.
LOW PROFILE TRACHEOSTOMY TUBE
K922749 · Concord/Portex · Sep 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281 · Trinity Laboratories, Inc. · Aug 1992
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992
TRACHEOSTOMY TUBE AND CUFF
K912124 · Concord/Portex · Aug 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469 · Bivona Medical Technologies · Jun 1991
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K903730 · Concord/Portex · Sep 1990