Cleared Traditional

K913859 - BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION

K913859 is an FDA 510(k) clearance for BIVONA FOME-CUF & AIR CUF, 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 156-day FDA review.

K913859 · Bivona Medical Technologies · Anesthesiology device
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Jan 1992
Decision
156d
Days
Class 2
Risk

K913859 is an FDA 510(k) clearance for the BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION. 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 30, 1992 after a review of 156 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 - K913859

510(k) Number K913859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date January 30, 1992
Days to Decision 156 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
16d slower than avg
Panel avg: 140d · This submission: 156d
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 K913859.
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
K922665 · Bivona Medical Technologies · Jan 1993
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K923878 · Bivona Medical Technologies · Dec 1992
TRACHEOSTOMY TUBE AND TUBE CUFF
K924660 · Applied Medical Resources · Dec 1992
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K914088 · Bivona Medical Technologies · Oct 1991
BIVONA CUFF MAINTENANCE DEVICE (CMD)
K914183 · Bivona Medical Technologies · Oct 1991
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K913270 · Bivona Medical Technologies · Aug 1991