Cleared Traditional

K930114 - TRACHEOSTOMY T-TUBE

K930114 is an FDA 510(k) clearance for TRACHEOSTOMY T-TUBE, manufactured by Invotec International, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K930114 · Invotec International, Inc. · Anesthesiology device
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Mar 1993
Decision
67d
Days
Class 2
Risk

K930114 is an FDA 510(k) clearance for the TRACHEOSTOMY T-TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Invotec International, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 19, 1993 after a review of 67 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 Invotec International, Inc. devices

FDA 510(k) Submission Details - K930114

510(k) Number K930114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1993
Decision Date March 19, 1993
Days to Decision 67 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 140d · This submission: 67d
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 118
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K930114.
BIVONA(R) ICU ENDOTRACHEAL TUBE
K931749 · Bivona Medical Technologies · Aug 1993
RAE(R) II TRACHEAL TUBE
K932280 · Mallinckrodt Medical · Jul 1993
LAZER-TRACH TRACHEAL TUBE
K922894 · Sheridan Catheter Corp. · May 1993
SAFE-T-TUBE RADIOPAQUE
K930150 · Boston Medical Products, Inc. · Feb 1993
MECONIUM SUCTION DEVICE (MSD)
K914370 · Vital Signs, Inc. · Jan 1993
ENDOTRACHEAL CPAP SET
K915277 · Vital Signs, Inc. · Mar 1992