510(k) Report

510(k) · Cleared

Recalled · Class I · 2014

Kimvent Microcuff Subglottic Suctioning Endotracheal Tube

K131254510(k) TraditionalCleared Aug 20, 2013110-day reviewClass II21 CFR 868.5730Recalls 5 (5 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kimberly-Clark Corp. · BTR Tube, Tracheal (W/Wo Connector)

Cleared on Aug 20, 2013 as substantially equivalent to K120985 (Kimberly-Clark Corp., 2012) after a 110-day review. Its family tree reaches back 4 generations to 1987. 1 of the 6 devices in its family, counting itself, has a Class I recall. It has been recalled 5 times, including 5 Class I recalls.

Decided
Aug 20, 2013
Review
110 days
Class
Class II
Product code
BTR
Recalls
5 (5 Class I)
Predicates
1

Its longest line of descent runs back 4 generations to K871204 (1987). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1997: 1 other ancestorK871204 · Cuffed Tracheal Tube (Multiple) · Mallinckrodt Critical Care · 1987 · recalledK082520 · Sealguard Evac Endotracheal and Endotracheal Tubes · Mallinckrodt Medical · 2008 · recalledK090352 · Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes · Covidien · 2009K120985 · Kimvent Microcuff Subglottic Suctioning · Kimberly-Clark Corp. · 20121985199019952000200520102015
Other ancestors, by generation 3 generations back: 1 other ancestor K120985 · Kimvent Microcuff Subglottic Suctioning · Kimberly-Clark Corp. · 2012K090352 · Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes · Covidien · 2009K082520 · Sealguard Evac Endotracheal and Endotracheal Tubes · Mallinckrodt Medical · 2008 · recalledK871204 · Cuffed Tracheal Tube (Multiple) · Mallinckrodt Critical Care · 1987 · recalled0
  1. Root · 4 generations backK871204 Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care · 1987 · Recalled
  2. 3 generations backK082520 Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · Recalled
  3. 2 generations backK090352 Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009
  4. 1 generation backK120985 Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp. · 2012
  5. This deviceK131254 Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K871204Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care19871
−3K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical20082
−2K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien2009—
−1K120985Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp.2012—
0 (this device)K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K131254, 1987–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K120985Kimvent Microcuff Subglottic Suctioning
Summary page 1
…substantially equivalent to the KimVent* MicrocufP* Subglottic Suctioning Endotracheal Tubes cleared in 510(k) K120985. Device KimVent* Microcuff Subglottic Suctioning Endotracheal Tubes are Description: availa…
Kimberly-Clark Corp.2012—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 17, 2014Class IZ-0867-2015Nonconforming Material/ComponentThe cuff inflation line may detach from the endotracheal tube during use.
Nov 17, 2014Class IZ-0865-2015Nonconforming Material/ComponentThe cuff inflation line may detach from the endotracheal tube during use.
Nov 17, 2014Class IZ-0866-2015Nonconforming Material/ComponentThe cuff inflation line may detach from the endotracheal tube during use.
Nov 17, 2014Class IZ-0868-2015Nonconforming Material/ComponentThe cuff inflation line may detach from the endotracheal tube during use.
Nov 17, 2014Class IZ-0869-2015Nonconforming Material/ComponentThe cuff inflation line may detach from the endotracheal tube during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
  • 2 of the 5 ancestors have a recall of any class.

How does its category compare?

All BTR devices

BTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · BTR

7in 2025

2007: 12008: 72009: 72010: 32011: 22012: 52013: 12014: 32015: 32016: 12017: 22018: 52019: 52020: 32021: 12022: 12023: 12024: 12025: 72026 (partial year): 2
2007high 7 (2008) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTR

258in 2025

2008: 61 days median2009: 135 days median2010: 179 days median2012: 261 days median2014: 308 days median2015: 262 days median2018: 242 days median2019: 211 days median2020: 246 days median2025: 258 days median
2007high 308 (2014) · low 61 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BTR

3in 2022

2007: 22009: 212014: 20, 19 Class I2016: 12020: 1, 1 Class I2021: 22022: 32026 (partial year): 1
2007high 21 (2009) · low 0 (2008)2026

Class I (20 since 2007) Class II/III not classified

Adverse event reports per year · BTR

1,799in 2025

2007: 1362008: 1692009: 1552010: 3352011: 4222012: 5112013: 8072014: 9852015: 1,0162016: 8362017: 8122018: 9772019: 1,3792020: 1,0702021: 1,3292022: 1,1322023: 1,3302024: 1,6782025: 1,799
2007high 1,799 (2025) · low 136 (2007)2025

MAUDE reports naming product code BTR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—2136
20087610169
2009713521155
201031790335
20112—0422
201252610511
20131—0807
2014330820 (19)985
2015326201,016
20161—1836
20172—0812
201852420977
2019521101,379
202032461 (1)1,070
20211—21,329
20221—31,132
20231—01,330
20241—01,678
2025725801,799
20262—1—

What is it indicated for?

KimVent* Microcuff* 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.

More from Kimberly-Clark Corp.

104 FDA decisions under this applicant name. See the company

  • K140963Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp. · 2014
  • K141294U by Kotex Security Unscented Menstrual TamponsKimberly-Clark Corp. · 2014
  • K131879KC 300 Surgical MaskKimberly-Clark Corp. · 20131 recall
  • K131841Kimberly-Clark Lavender Nitrile Powder-Free Exam GloveKimberly-Clark Corp. · 2013
  • K120985Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp. · 2012

Recent decisions in BTR

The BTR category page

  • K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026
  • K253437Spiro-VISTASpiro Robotics · 2026
  • K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless…Covidien, LLC · 2025
  • K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube…Covidien, LLC · 2025
  • K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC · 2025

https://510kreport.com/device/K131254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131254: Kimvent Microcuff Subglottic Suctioning Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131254

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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