Cleared Traditional

K862238 - BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE

K862238 is an FDA 510(k) clearance for BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE, manufactured by Bivona Medical Technologies. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K862238 · Bivona Medical Technologies · Anesthesiology device
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Oct 1986
Decision
125d
Days
Class 2
Risk

K862238 is an FDA 510(k) clearance for the BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE. 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 15, 1986 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K862238

510(k) Number K862238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1986
Decision Date October 15, 1986
Days to Decision 125 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
15d faster than avg
Panel avg: 140d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

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 154
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K862238.
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · Mallinckrodt Critical Care · Apr 1987
HOOD BIFURCATED T-TUBE
K864533 · Hood Laboratories · Mar 1987
WHITE-SIPOSS TUBE, CAT NO WS-1
K862950 · American Omni Medical, Inc. · Oct 1986
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · Mallinckrodt Critical Care · Aug 1986
ENDOTRACHEAL TUBE, ACCESSORY
K862347 · Sheridan Catheter Corp. · Jul 1986
LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
K860901 · Mallinckrodt Critical Care · Jun 1986