Cleared Traditional

K932647 - WIRE REINFORCED ENDOTRACHEAL TUBE

K932647 is an FDA 510(k) clearance for WIRE REINFORCED ENDOTRACHEAL 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 153-day FDA review.

K932647 · Vitaid, Ltd. · Anesthesiology device
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Nov 1993
Decision
153d
Days
Class 2
Risk

K932647 is an FDA 510(k) clearance for the WIRE REINFORCED ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Vitaid, Ltd. (Lewiston, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitaid, Ltd. devices

FDA 510(k) Submission Details - K932647

510(k) Number K932647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date November 02, 1993
Days to Decision 153 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
13d slower than avg
Panel avg: 140d · This submission: 153d
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 K932647.
ENDOPLUS
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RAE II TRACHEAL TUBE
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K934465 · Smiths Industries Medical Systems, Inc. · Jan 1994
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · Bivona Medical Technologies · Oct 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K925505 · Rusch, Inc. · Sep 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
K925507 · Rusch, Inc. · Sep 1993