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Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults

by Kimberly Clark Corporation

510(k) K113333

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113333 Date11 May 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTR
FDA applicant
Kimberly-Clark Corporation
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults is a device designed for airway management by nasal or oral intubation of the trachea in adult patients. It is a tracheal tube with a microcuff and is classified under product code BTR for regulatory purposes.

This device is supplied as a single-use item and is intended for use in adult patients requiring airway management. The device has received FDA 510(k) clearance with the K number K113333 and is classified as Class II. It is manufactured by Kimberly-Clark Corporation and is not indicated for MRI environments.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kimberly-Clark Kim Vent Microcuff Endotracheal Tube used for?

    The Kim Vent Microcuff Endotracheal Tube is designed for airway management by nasal or oral intubation of the trachea in adult patients requiring secure airway access during medical procedures.

  • Is this endotracheal tube reusable or single-use?

    This device is supplied as a single-use item and should not be reused. Single-use design helps prevent cross-contamination between patients and ensures optimal performance.

  • What regulatory approvals does this device have?

    The Kimberly-Clark Kim Vent Microcuff Endotracheal Tube has received FDA 510(k) clearance with K number K113333 and is classified as Class II under product code BTR for regulatory purposes.

  • Is this device suitable for use in MRI environments?

    No, this endotracheal tube is not indicated for use in MRI environments. Healthcare providers should select appropriate devices specifically designed for MRI settings when such procedures are required.