Cleared Traditional

K810436 - TRACHEOSTOMA VENT

K810436 is the FDA 510(k) clearance for TRACHEOSTOMA VENT by Bivona Medical Technologies. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810436 · Bivona Medical Technologies · Anesthesiology device
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Mar 1981
Decision
13d
Days
Class 2
Risk

K810436 is an FDA 510(k) clearance for the TRACHEOSTOMA VENT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 13 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 K810436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1981
Decision Date March 04, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTO Tube, Tracheostomy (w/wo Connector)
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 23
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K810436.
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · Shiley, Inc. · May 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106 · Shiley, Inc. · Feb 1981
TRACH CARE KIT
K790437 · Abco Dealers, Inc. · Apr 1979
ENDOTRACHEAL TUBE
K772138 · Medline Industries, Inc. · Dec 1977