Cleared Traditional

K894669 - LASER SHIELDING TUBE

K894669 is an FDA 510(k) clearance for LASER SHIELDING TUBE, manufactured by Vitaid, Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K894669 · Vitaid, Ltd. · Anesthesiology device
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Oct 1989
Decision
81d
Days
Class 2
Risk

K894669 is an FDA 510(k) clearance for the LASER SHIELDING TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Vitaid, Ltd. (M5m 2e1, CA). The FDA issued a Cleared decision on October 13, 1989 after a review of 81 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 Vitaid, Ltd. devices

FDA 510(k) Submission Details - K894669

510(k) Number K894669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 13, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
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 151
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K894669.
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
K912290 · Boston Medical Products, Inc. · Aug 1991
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
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CUFFED LINDER NASOTRACHEAL AIRWAY
K900457 · Polamedco, Inc. · Apr 1990
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · The Kendal Co. · Jun 1989
LINDER NASOTRACHEAL AIRWAY
K881496 · Polamedco, Inc. · May 1988
NDYAG LASER TRACHEAL TUBE
K880960 · Sheridan Catheter Corp. · Apr 1988