Cleared Traditional

K922665 - BIVONA HYPERFLEX TRACHEOSTOMY TUBE

K922665 is an FDA 510(k) clearance for BIVONA HYPERFLEX TRACHEOSTOMY TUBE, manufactured by Bivona Medical Technologies. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K922665 · Bivona Medical Technologies · Anesthesiology device
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Jan 1993
Decision
220d
Days
Class 2
Risk

K922665 is an FDA 510(k) clearance for the BIVONA HYPERFLEX TRACHEOSTOMY TUBE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on January 7, 1993 after a review of 220 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 - K922665

510(k) Number K922665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date January 07, 1993
Days to Decision 220 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
80d slower than avg
Panel avg: 140d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 72
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K922665.
TRACHEOSTOMY CARE TRAY
K923156 · Orion Life Systems, Inc. · Aug 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020 · Customed, Inc. · Jul 1993
TRACHEOSTOMY CARE KIT
K924243 · Transidyne General Corp. · Jun 1993
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K923878 · Bivona Medical Technologies · Dec 1992
TRACHEOSTOMY TUBE AND TUBE CUFF
K924660 · Applied Medical Resources · Dec 1992
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
K913859 · Bivona Medical Technologies · Jan 1992