Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults
510(k) K113333
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113333 | Date11 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Kimberly-Clark Corporation
Questions
AI-generated answers, 6 Oct 2026
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.