Cleared Traditional

LASER SHIELDING TUBE (K894669) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894669 · Vitaid, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 54
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K894669.
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · C.R. Bard, Inc. · Nov 2007
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · Mallinckrodt Critical Care · Nov 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · Mallinckrodt Critical Care · Apr 1987
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · Mallinckrodt Critical Care · Aug 1986