Cleared Traditional

K914183 - BIVONA CUFF MAINTENANCE DEVICE (CMD)

K914183 is an FDA 510(k) clearance for BIVONA CUFF MAINTENANCE DEVICE (CMD), 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 35-day FDA review.

K914183 · Bivona Medical Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
35d
Days
Class 2
Risk

K914183 is an FDA 510(k) clearance for the BIVONA CUFF MAINTENANCE DEVICE (CMD). 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 23, 1991 after a review of 35 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 - K914183

510(k) Number K914183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date October 23, 1991
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 K914183.
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
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K914088 · Bivona Medical Technologies · Oct 1991
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K913270 · Bivona Medical Technologies · Aug 1991
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K912967 · Bivona Medical Technologies · Jul 1991
TRACHEOSTOMY CARE KIT
K910362 · Megadyne Medical Products, Inc. · Apr 1991