Cleared Traditional

K951696 - ENDOTRACHEAL TUBE

K951696 is an FDA 510(k) clearance for 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 40-day FDA review.

K951696 · Unomedical Sdn Bhd · Anesthesiology device
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May 1995
Decision
40d
Days
Class 2
Risk

K951696 is an FDA 510(k) clearance for the 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 May 22, 1995 after a review of 40 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.

FDA 510(k) Submission Details - K951696

510(k) Number K951696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1995
Decision Date May 22, 1995
Days to Decision 40 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 140d · This submission: 40d
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 233
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K951696.
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
K954754 · Unomedical Sdn Bhd · Dec 1995
LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
K953368 · Karl Storz Endoskop GmbH · Sep 1995
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
K935842 · Rusch, Inc. · May 1995
PEDIATRIC ENDOTRACHEAL TUBE
K951697 · Unomedical Sdn Bhd · May 1995
PRIMA GUEDEL AIRWAYS
K952013 · Prima, Inc. · May 1995
EDD
K924997 · Arc Medical, Inc. · Mar 1995
K951696 · ENDOTRACHEAL TUBE
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