Cleared Traditional

K885130 - MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY...

K885130 is the FDA 510(k) clearance for MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY... by Bivona Medical Technologies. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K885130 · Bivona Medical Technologies · Anesthesiology device
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Feb 1989
Decision
77d
Days
Class 2
Risk

K885130 is an FDA 510(k) clearance for the MODIFIED AIRE-CUF SILICONE 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 February 27, 1989 after a review of 77 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

Submission Details

510(k) Number K885130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date February 27, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.