510(k) · Cleared
ClearedKimvent Microcuff Subglottic Suctioning
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Dec 19, 2012 as substantially equivalent to K090352 (Covidien, 2009) after a 261-day review. Its family tree reaches back 3 generations to 1987. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 19, 2012
- Review
- 261 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871204 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK871204 Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care · 1987 · Recalled
- 2 generations backK082520 Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · Recalled
- 1 generation backK090352 Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009
- This deviceK120985 Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp. · 2012
- Descendant · cites it directly · 0 of its ownK131254 Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 2013 · Recalled (Class I)
Class I recalls in this family
- K131254 Kimvent Microcuff Subglottic Suctioning…cites it directly · 2013
Most influential descendants
Showing 1 of 1 · See all- K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871204 | Cuffed Tracheal Tube (Multiple) | Mallinckrodt Critical Care | 1987 | 1 |
| −2 | K082520 | Sealguard Evac Endotracheal and Endotracheal Tubes | Mallinckrodt Medical | 2008 | 2 |
| −1 | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes | Covidien | 2009 | — |
| 0 (this device) | K120985 | Kimvent Microcuff Subglottic Suctioning | Kimberly-Clark Corp. | 2012 | — |
| +1 | K131254 | Kimvent Microcuff Subglottic Suctioning Endotracheal Tube | Kimberly-Clark Corp. | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesSummary page 1…uctioning Endlotracheal Tubes are substantially equivalent to the predicate device, TaperGuard Evacm Endlotrachael Tubes (K090352). Device Description: KimVenr* MicrocuWf Subglottic Suctioning Endotracheal Tubes are available in ad… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131254 | Kimvent Microcuff Subglottic Suctioning Endotracheal Tube Class I | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K131254 (Kimberly-Clark Corp., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090352.
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* Microcufr*Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120985: Kimvent Microcuff Subglottic Suctioning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120985
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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