510(k) Report

510(k) · Cleared

Cleared

Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner Cannula

K051416510(k) SpecialCleared Jun 16, 200515-day reviewClass II21 CFR 868.5800

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

Mallinckrodt Medical · JOH Tube Tracheostomy And Tube Cuff

Cleared on Jun 16, 2005 as substantially equivalent to K003315 (Mallinckrodt, Inc., 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000.

Decided
Jun 16, 2005
Review
15 days
Class
Class II
Product code
JOH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003315 (2000). No later device cites it as a predicate yet.

K003315 · Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula · Mallinckrodt, Inc. · 2000 · recalled2000200220042006
K003315 · Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula · Mallinckrodt, Inc. · 2000 · recalled0
  1. Root · 1 generation backK003315 Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and…Mallinckrodt, Inc. · 2000 · Recalled
  2. This deviceK051416 Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner…Mallinckrodt Medical · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003315Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner…Mallinckrodt, Inc.20001
0 (this device)K051416Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaMallinckrodt Medical2005—
FIG. 1 — Lineage of K051416, 2000–2005Source: 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 JOH? 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 JOH device

  1. #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K003315Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula
Summary page 1
…Class 11; Tracheostomy tube and cuff21 CFR §868.5800 Legally Marketed Mallinckrodt, Inc, K0033 15, (Unmodified) Device: Shiley TracheoSoft XLT Extended Length…
Mallinckrodt, Inc.20001

Also cleared against K003315: 1 other device →

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?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K003315.

How does its category compare?

All JOH devices

JOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOH

1in 2025

2007: 12008: 22009: 12010: 22012: 12013: 32014: 32015: 32016: 12017: 12018: 32019: 22020: 12021: 22025: 1
2007high 3 (2013) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOH

137in 2018

2013: 407 days median2014: 218 days median2015: 179 days median2018: 137 days median
2007high 407 (2013) · low 137 (2018)2026

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

Recalls per year · JOH

1in 2023

2007: 12009: 12010: 732011: 42016: 2, 1 Class I2020: 12023: 12026 (partial year): 1
2007high 73 (2010) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · JOH

986in 2025

2007: 1672008: 1022009: 1952010: 1,2702011: 5872012: 5002013: 5442014: 5062015: 5082016: 5722017: 4412018: 8122019: 1,0192020: 7912021: 1,0412022: 1,6322023: 1,2332024: 1,1032025: 986
2007high 1,632 (2022) · low 102 (2008)2025

MAUDE reports naming product code JOH, 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—1167
20082—0102
20091—1195
20102—731,270
20110—4587
20121—0500
201334070544
201432180506
201531790508
20161—2 (1)572
20171—0441
201831370812
20192—01,019
20201—1791
20212—01,041
20220—01,632
20230—11,233
20240—01,103
20251—0986
20260—1—

What is it indicated for?

The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula are intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff is intended to establish a seal between the tracheal wall and the tracheostomy tube. This device is intended to be a component of a life-sustaining device to be used with adult patients.

Indications for use as stated in the FDA summary.

Also cleared against K003315

1 other device cites the same predicate.

  • K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc. · 20031 recall

More from Mallinckrodt Medical

43 FDA decisions under this applicant name. See the company

  • K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 20082 recalls
  • K972258HI-Care Closed Suction SystemMallinckrodt Medical · 1997
  • K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal…Mallinckrodt Medical · 1997
  • K963732Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner CannulaMallinckrodt Medical · 19972 recalls
  • K955721Cuffed Oropharyngeal Airway (Copa)Mallinckrodt Medical · 1997

Recent decisions in JOH

The JOH category page

  • K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula…Covidien, LLC · 2025
  • K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra…Smiths Medical Asd, Inc. · 2021
  • K203362TRACOE varioTracoe Medical GmbH · 2021
  • K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
  • K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 20192 Class I recalls

https://510kreport.com/device/K051416 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051416: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051416

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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