510(k) Report

510(k) · Cleared

Recalled · Class I · 2023

Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye

K931163510(k) TraditionalCleared Jun 23, 1993107-day reviewClass II21 CFR 868.5730Recalls 12 (12 Class I)

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

Rusch, Inc. · BTR Tube, Tracheal (W/Wo Connector)

Cleared on Jun 23, 1993 after a 107-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 28 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it. It has been recalled 12 times, including 12 Class I recalls.

Decided
Jun 23, 1993
Review
107 days
Class
Class II
Product code
BTR
Recalls
12 (12 Class I)
Predicates
0

27 later devices descend from it, 4 citing it directly. 2 of the 28 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2002: 2 descendants cleared2005: 2 descendants cleared2017: 1 descendant cleared2011: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared2008: 2 descendants cleared2010: 1 descendant cleared2009: 2 descendants cleared2012: 2 descendants cleared2019: 4 descendants cleared2016: 1 descendant cleared2020: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared2018: 2 descendants cleared2023: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993
  2. Descendant · cites it directly · 23 of its ownK042683 Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK111401 Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012
  4. Descendant · 2 generations on · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
  5. Descendant · 3 generations on · 3 of its ownK151381 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015
  6. Descendant · 2 generations on · 3 of its ownK093126 Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2002: 22005: 22008: 22009: 22010: 12011: 12012: 22014: 12015: 12016: 12017: 12018: 22019: 42020: 12022: 12023: 12024: 12025: 1
2002high 4 (2019) · low 0 (2003)2026

Class I recalls in this family

  • K110269 Well Lead Endotracheal Tube with Evacuation…2 generations on · 2011

Most influential descendants

Showing 5 of 27 · See all
  • K042683Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005 · cites it directly23descendants
  • K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012 · 2 generations on5descendants
  • K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · 2 generations on5descendants
  • K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015 · 3 generations on3descendants
  • K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc.1993—
+1K042683Well Lead Endotracheal TubeWell Lead Medical Instruments20051
+2K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd.2012—
+2K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments2008—
+3K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien2015—
+2K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200520
200820
200920
201010
201111
201220
201410
201510
201610
201710
201820
201940
202010
202210
202310
202410
202510
FIG. 1 — Lineage of K931163, 1993–2025Source: 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 12.5 · 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K042683Well Lead Endotracheal TubeWell Lead Medical Instruments200523
K041311Tiger Endotracheal Tubes (Various Models and Sizes)Tiger Medical Products, Ltd.20052
K021540Rusch Edgar TubeRusch Intl.20021
K023964Rusch Microlaryngeal TubeRusch Intl.20020

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

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2023Class IZ-1945-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1877-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1940-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1948-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1950-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1949-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1947-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1942-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1941-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1944-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1946-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1943-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

The 5 latest of 12 recalls; the web page lists all.

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

What does this lineage say?

  • Of its descendants, K042683 (Well Lead Medical Instruments, 2005) has gone furthest, with 23 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 Rusch, Inc.

26 FDA decisions under this applicant name. See the company

  • K010420Rusch MMG/O'neil CatheterRusch, Inc. · 20013 recalls
  • K993528Rusch Emergency MaskRusch, Inc. · 2000
  • K993194Rusch Manual Resuscitator BagRusch, Inc. · 2000
  • K980870Rusch Silicone Foley CatheterRusch, Inc. · 1998
  • K974419Rusch Simplastic Councill Tip CatheterRusch, Inc. · 1998

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/K931163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931163

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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