Cleared Traditional

K954754 - WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE

K954754 is an FDA 510(k) clearance for WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE, manufactured by Unomedical Sdn Bhd. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K954754 · Unomedical Sdn Bhd · Anesthesiology device
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Dec 1995
Decision
53d
Days
Class 2
Risk

K954754 is an FDA 510(k) clearance for the WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Unomedical Sdn Bhd (West Malaysia, MY). The FDA issued a Cleared decision on December 8, 1995 after a review of 53 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 Unomedical Sdn Bhd devices

FDA 510(k) Submission Details - K954754

510(k) Number K954754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date December 08, 1995
Days to Decision 53 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
87d faster than avg
Panel avg: 140d · This submission: 53d
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 165
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K954754.
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K960795 · Vygon Corp. · May 1996
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
K954585 · Rusch Intl. · May 1996
HEBELER SAFE-T-TUBE
K960450 · Boston Medical Products, Inc. · Apr 1996
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
K935842 · Rusch, Inc. · May 1995
PRIMA GUEDEL AIRWAYS
K952013 · Prima, Inc. · May 1995
QUICK-LOCK
K945816 · B&B Medical Technologies, Inc. · Jan 1995