KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE— 510(k) K131254

Clearance details

Applicant

Kimberly-Clark Corp.

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

2013-05-02

Decision date

2013-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roswell, GA, US

• K251794 — Tenax® Laser Resistant Endotracheal Tube2026-09-03
• K253437 — Spiro-VISTA2026-06-12
• K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)2025-10-06
• K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced2025-09-25
• K243579 — AeroJet Ventilation Catheter2025-08-13

• K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP2014-11-10
• K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS2014-08-25
• K131879 — KC 300 SURGICAL MASK2013-12-20
• K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE2013-11-07
• K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING2012-12-19

Death

92

Injury

1,263

Malfunction

7,475

Other

2

Total

8,832

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0865-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.Class I·Terminated·Halyard Health·20141117
• Z-0866-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.Class I·Terminated·Halyard Health·20141117
• Z-0867-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.Class I·Terminated·Halyard Health·20141117
• Z-0868-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.Class I·Terminated·Halyard Health·20141117
• Z-0869-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.Class I·Terminated·Halyard Health·20141117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131254.