Cleared Traditional

K872366 - AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE

K872366 is an FDA 510(k) clearance for AIRE-CUF POLYESTER RE-ENFORCED ENDOTRAC..., 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 60-day FDA review.

K872366 · Bivona Medical Technologies · Anesthesiology device
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Aug 1987
Decision
60d
Days
Class 2
Risk

K872366 is an FDA 510(k) clearance for the AIRE-CUF POLYESTER RE-ENFORCED 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 August 17, 1987 after a review of 60 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

FDA 510(k) Submission Details - K872366

510(k) Number K872366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1987
Decision Date August 17, 1987
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
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 K872366.
NDYAG LASER TRACHEAL TUBE
K880960 · Sheridan Catheter Corp. · Apr 1988
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · Mallinckrodt Critical Care · Nov 1987
NASOGASTRIC VOICETUBE
K871632 · American Omni Medical, Inc. · Sep 1987
BELL/MCKAY TRACHEAL TUBE
K872616 · Sheridan Catheter Corp. · Aug 1987
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870387 · American Pharmaseal Div. Ahsc · May 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · Mallinckrodt Critical Care · Apr 1987