Cleared Traditional

K853502 - VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEP...

K853502 is the FDA 510(k) clearance for VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEP... by Bivona Medical Technologies. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K853502 · Bivona Medical Technologies · Anesthesiology device
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Oct 1985
Decision
41d
Days
Class 2
Risk

K853502 is an FDA 510(k) clearance for the VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on October 1, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 K853502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1985
Decision Date October 01, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 60
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K853502.
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K861461 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · Shiley, Inc. · May 1986
BRANDT TRACHEAL TUBE(TENTATIVE)
K852025 · Mallinckrodt Critical Care · Aug 1985
UNCUFFED HI-LO JET TRACHEAL TUBE
K852493 · Mallinckrodt Critical Care · Jul 1985
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · Sherwood Medical Co. · Feb 1985