Cleared Traditional

K894613 - BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE

K894613 is an FDA 510(k) clearance for BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY..., 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 85-day FDA review.

K894613 · Bivona Medical Technologies · Anesthesiology device
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Oct 1989
Decision
85d
Days
Class 2
Risk

K894613 is an FDA 510(k) clearance for the BIVONA FOME-CUF ADJUSTABLE 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 October 13, 1989 after a review of 85 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 - K894613

510(k) Number K894613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date October 13, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K894613.
HOOD SPEAKING VALVE
K897059 · Hood Laboratories · Mar 1990
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K896547 · Bivona Medical Technologies · Jan 1990
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · Bivona Medical Technologies · Jan 1990
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614 · Bivona Medical Technologies · Oct 1989
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · Shiley, Inc. · Jul 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129 · Bivona Medical Technologies · Feb 1989