510(k) Report

510(k) · Cleared

Cleared

Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, Sterile

K954585510(k) TraditionalCleared May 10, 1996221-day reviewClass II21 CFR 868.5730

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

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

Cleared on May 10, 1996 as substantially equivalent to K844296 (Sheridan Catheter Corp., 1984) and 3 other predicates after a 221-day review. Its family tree reaches back 1 generation to 1983.

Decided
May 10, 1996
Review
221 days
Class
Class II
Product code
BTR
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K830352 (1983). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1986: 1 other ancestor1984: 2 other ancestorsK830352 · Reinforced Silicone Tracheal Tube · Portex, Inc. · 19831980198519901995
Other ancestors, by generation 1 generation back: 3 other ancestors K830352 · Reinforced Silicone Tracheal Tube · Portex, Inc. · 19830
  1. Root · 1 generation backK830352 Reinforced Silicone Tracheal TubePortex, Inc. · 1983
  2. This deviceK954585 Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube -…Rusch Intl. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830352Reinforced Silicone Tracheal TubePortex, Inc.1983—
0 (this device)K954585Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, SterileRusch Intl.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198610
FIG. 1 — Lineage of K954585, 1983–1996Source: 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.

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. #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? (4)

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
*K844296Tracheal Tube, Reinforced, Cuffed
Summary page 1
…ile for tracheal intubation applied for in this application is substantially equivalent in design, use and materials to the: Sheridan Reinforced Uncuffed Tracheal Tube - K844296 & K860105 SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube - K830352 NCC/Mallinckrodt Reinforced tracheal tube unc…
Sheridan Catheter Corp.1984—
*K860105Spiral-Flex
Summary page 1
…acheal intubation applied for in this application is substantially equivalent in design, use and materials to the: Sheridan Reinforced Uncuffed Tracheal Tube - K844296 & K860105 SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube - K830352 NCC/Mallinckrodt Reinforced tracheal tube uncuffed with…
Sheridan Catheter Corp.1986—
*K830352Reinforced Silicone Tracheal Tube
Summary page 1
…ent in design, use and materials to the: Sheridan Reinforced Uncuffed Tracheal Tube - K844296 & K860105 SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube - K830352 NCC/Mallinckrodt Reinforced tracheal tube uncuffed without Magill curve - K841872 currently in inter-state commerce. The device,…
Portex, Inc.1983—
*K841872Uncuffed Reinforced Tracheal Tube
Summary page 1
…e - K844296 & K860105 SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube - K830352 NCC/Mallinckrodt Reinforced tracheal tube uncuffed without Magill curve - K841872 currently in inter-state commerce. The device, which is equivalent to other devices currently being marketed, consists of a clea…
Mallinckrodt Critical Care1984—

Also cleared against K844296: 2 other devices →

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?

  • None of the 4 ancestors has a recall.
  • 2 other devices also cite its predicate K844296.

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—

What is it indicated for?

The device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K844296

2 other devices cite the same predicate.

  • K192324Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc. · 2019
  • K955495Rusch Reinforced Trachael Tube Cuffed, SterileRusch, Inc. · 1996

More from Rusch Intl.

43 FDA decisions under this applicant name. See the company

  • K033023Intermittent Urethral CathetersRusch Intl. · 2003
  • K030559Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemRusch Intl. · 2003
  • K023666Rusch Guided Cholangiography CatheterRusch Intl. · 2003
  • K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 20032 recalls
  • K023964Rusch Microlaryngeal TubeRusch Intl. · 2002

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/K954585 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954585: Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954585

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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