Cleared Traditional

K113333 - KIMBERLY-CLARK KIM VENT MICROCUFF ENDOT...

K113333 is an FDA 510(k) clearance for KIMBERLY-CLARK KIM VENT MICROCUFF ENDOT..., manufactured by Kimberly Clark Corporation. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K113333 · Kimberly Clark Corporation · Anesthesiology device
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May 2012
Decision
179d
Days
Class 2
Risk

K113333 is an FDA 510(k) clearance for the KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Kimberly Clark Corporation (Roswell, US). The FDA issued a Cleared decision on May 11, 2012 after a review of 179 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 Kimberly Clark Corporation devices

FDA 510(k) Submission Details - K113333

510(k) Number K113333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date May 11, 2012
Days to Decision 179 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 140d · This submission: 179d
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 134
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