510(k) · Cleared
ClearedKimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corporation · BTR Tube, Tracheal (W/Wo Connector)
Cleared on May 11, 2012 as substantially equivalent to K050803 (Vitaid, Ltd., 2005) after a 179-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- May 11, 2012
- Review
- 179 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852025 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK852025 Brandt Tracheal Tube (Tentative)Mallinckrodt Critical Care · 1985
- 1 generation backK050803 Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed…Vitaid, Ltd. · 2005 · Recalled
- This deviceK113333 Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for AdultsKimberly-Clark Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852025 | Brandt Tracheal Tube (Tentative) | Mallinckrodt Critical Care | 1985 | — |
| −1 | K050803 | Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes | Vitaid, Ltd. | 2005 | 3 |
| 0 (this device) | K113333 | Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults | Kimberly-Clark Corporation | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050803 | Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET TubesSummary page 1…otracheal Tubes for Adults (sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0 mm) are substantially equivalent to the Adult Cuffed ET Tubes; Standard cleared under K050803. Both the Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults and the predicate device have the same intended use a… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 19.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K050803.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are indicated for airway management by nasal or oral intubation of the trachea in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113333: Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113333
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026