510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Cuffed Tracheal Tube (Multiple)

K871204510(k) TraditionalCleared Apr 21, 198727-day reviewClass II21 CFR 868.5730Recalls 1

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

Mallinckrodt Critical Care · BTR Tube, Tracheal (W/Wo Connector)

Cleared on Apr 21, 1987 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled once.

Decided
Apr 21, 1987
Review
27 days
Class
Class II
Product code
BTR
Recalls
1
Predicates
0

16 later devices descend from it, 5 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2009: 1 descendant cleared1997: 1 descendant cleared2012: 2 descendants cleared2008: 2 descendants cleared2004: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared, 1 with a Class I recall12018: 2 descendants cleared2016: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2013: 1 descendant cleared, 1 with a Class I recall12022: 1 descendant cleared1990200020102020
  1. This deviceK871204 Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care · 1987
  2. Descendant · cites it directly · 11 of its ownK082520 Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · Recalled
  3. Descendant · cites it directly · 6 of its ownK090352 Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009
  4. Descendant · 2 generations on · 3 of its ownK093126 Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010
  5. Descendant · 3 generations on · 2 of its ownK150157 AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016
  6. Descendant · 2 generations on · 2 of its ownK110269 Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · Recalled (Class I)

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1997: 12004: 12008: 22009: 12010: 12011: 12012: 22013: 12016: 12018: 22019: 12020: 12022: 1
1997high 2 (2008) · low 0 (1998)2026

Class I recalls in this family

  • K110269 Well Lead Endotracheal Tube with Evacuation…2 generations on · 2011
  • K131254 Kimvent Microcuff Subglottic Suctioning…3 generations on · 2013

Most influential descendants

Showing 5 of 16 · See all
  • K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · cites it directly11descendants
  • K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009 · cites it directly6descendants
  • K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010 · 2 generations on3descendants
  • K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016 · 3 generations on2descendants
  • K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871204Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care1987—
+1K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical20082
+1K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien2009—
+2K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd.2010—
+3K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.2016—
+2K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd.2011Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200410
200820
200910
201010
201111
201220
201311
201610
201820
201910
202010
202210
FIG. 1 — Lineage of K871204, 1987–2022Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have 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 12.6 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical200811
K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien20096
K031794Endoflex Tracheal TubeMerlyn Associates, Inc.20041
K112915Spirtius Cuff Inflation SyringeSpiritus Technologies, LLC20120
K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 10, 2023Class IIZ-1318-2023Process controlDue to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

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.

  • K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls

What does this lineage say?

  • Of its descendants, K082520 (Mallinckrodt Medical, 2008) has gone furthest, with 11 descendants of its own.

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.

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—

More from Mallinckrodt Critical Care

92 FDA decisions under this applicant name. See the company

  • K880343Burney Gallbladder Catheter KitMallinckrodt Critical Care · 1989
  • K874605HI-LO Temp (R) Myocardial Temperature SensorMallinckrodt Critical Care · 1988
  • K874514HI-LO Temp (R) General Purpose Temperature ProbeMallinckrodt Critical Care · 1988
  • K874568HI-LO Temp (R) Model 8700 Patient Temp MonitorMallinckrodt Critical Care · 1988
  • K874404HI-LO Temp (R) Skin Temperature SensorMallinckrodt Critical Care · 1987

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/K871204 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871204: Cuffed Tracheal Tube (Multiple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871204

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026