510(k) Report

510(k) · Cleared

Recalled · Class I · 2012

Shikey Tracheostomy Tubes and Accessories

K962173510(k) TraditionalCleared Oct 4, 1996121-day reviewClass II21 CFR 868.5800Recalls 23 (1 Class I)

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 Oct 4, 1996 as substantially equivalent to K792222 (Shiley, Inc., 1979) and 9 other predicates after a 121-day review. Its family tree reaches back 1 generation to 1979. 3 of the 18 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 23 times, including a Class I recall.

Decided
Oct 4, 1996
Review
121 days
Class
Class II
Product code
JOH
Recalls
23 (1 Class I)
Predicates
10

Its longest line of descent runs back 1 generation to K792222 (1979). 10 ancestors in all. 7 later devices descend from it, 5 citing it directly. 3 of the 18 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor1984: 1 other ancestor1982: 1 other ancestor1981: 4 other ancestors2015: 2 descendants cleared, 2 with a Class I recall22007: 1 descendant cleared1997: 1 descendant cleared2003: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant clearedK792222 · Shiley Low Pressure Thin-Cuffed Trach. · Shiley, Inc. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors 1 generation forward: 5 descendants, 2 with a Class I recall22 generations forward: 2 descendants K792222 · Shiley Low Pressure Thin-Cuffed Trach. · Shiley, Inc. · 19790
  1. Root · 1 generation backK792222 Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc. · 1979
  2. This deviceK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996
  3. Descendant · cites it directly · 3 of its ownK142296 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner…Covidien · 2015 · Recalled (Class I)
  4. Descendant · cites it directly · 1 of its ownK150844 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner…Covidien · 2015 · Recalled (Class I)
  5. Descendant · 2 generations on · 0 of its ownK251313 Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff…Covidien, LLC · 2025
  6. Descendant · 2 generations on · 0 of its ownK193077 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
  7. Descendant · cites it directly · 0 of its ownK062104 Talking TrachEngineered Medical Systems, Inc. · 2007

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1997: 12003: 12007: 12015: 22020: 12025: 1
1997high 2 (2015) · low 0 (1998)2026

Class I recalls in this family

  • K142296 Shiley Adult Flexible Tracheostomy Tube…cites it directly · 2015
  • K150844 Shiley Adult Flexible Tracheostomy Tube…cites it directly · 2015

Most influential descendants

Showing 5 of 7 · See all
  • K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…Covidien · 2015 · cites it directly3descendants
  • K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…Covidien · 2015 · cites it directly1descendant
  • K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with…Covidien, LLC · 2025 · 2 generations on0descendants
  • K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020 · 2 generations on0descendants
  • K062104Talking TrachEngineered Medical Systems, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792222Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc.1979—
0 (this device)K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical1996—
+1K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula…Covidien2015Class I
+1K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula…Covidien2015Class I
+2K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal…Covidien, LLC2025—
+2K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien2020—
+1K062104Talking TrachEngineered Medical Systems, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198140
198210
198410
198710
198810
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200310
200710
201522
202010
202510
FIG. 1 — Lineage of K962173, 1979–2025Source: 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), 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.

3 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 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
Get a 510(k) Report

What was it cleared against? (11)

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
*K792222Shiley Low Pressure Thin-Cuffed Trach.
Summary page 1
…e and tube cuff, 21 CFR 868.5800 Predicate Devices: Predicate Device Name | Product Designation 510(k) Number = = —— 1. Shiley Low Pressure, Cuffed Tracheostomy Tube LPC K792222, 12/18/79 K811033; 5/13/81 2. Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy ' Tube FEN K812302, 9/8/81 3. Shiley Cuffless…
Shiley, Inc.1979—
*K811033Shiley Low Pressure Thin-Cuffed Trach
Summary page 1
…1 CFR 868.5800 Predicate Devices: Predicate Device Name | Product Designation 510(k) Number = = —— 1. Shiley Low Pressure, Cuffed Tracheostomy Tube LPC K792222, 12/18/79 K811033; 5/13/81 2. Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy ' Tube FEN K812302, 9/8/81 3. Shiley Cuffless Tracheostomy Tube…
Shiley, Inc.1981—
*K812302Shiley Fenestrated Low Press. Cuffed
Summary page 1
…Number = = —— 1. Shiley Low Pressure, Cuffed Tracheostomy Tube LPC K792222, 12/18/79 K811033; 5/13/81 2. Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy ' Tube FEN K812302, 9/8/81 3. Shiley Cuffless Tracheostomy Tubes CFS (non-fenestrated) pre-amendment CFEN (fenestrated) 4. Shiley Laryngectomy Tube…
Shiley, Inc.19811
*K821993Shiley Laryngectomy Tube
Summary page 1
…ffed Tracheostomy ' Tube FEN K812302, 9/8/81 3. Shiley Cuffless Tracheostomy Tubes CFS (non-fenestrated) pre-amendment CFEN (fenestrated) 4. Shiley Laryngectomy Tube LGT K821993, 8/12/82 5. Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube DCT K811447, 6/26/81 6. Shiley Disposable Cannula,…
Shiley, Inc.1982—
*K811447Shiley Disposable Cannula Trach. Tube
Summary page 1
…n-fenestrated) pre-amendment CFEN (fenestrated) 4. Shiley Laryngectomy Tube LGT K821993, 8/12/82 5. Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube DCT K811447, 6/26/81 6. Shiley Disposable Cannula, Fenestrated, Low Pressure, DFEN K843729, 10/19/84 Cuffed Tracheostomy Tube K865061, 1/15/8…
Shiley, Inc.1981—
*K843729Shiley Dispos. Cannula Fenestrated Low
Summary page 1
…K821993, 8/12/82 5. Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube DCT K811447, 6/26/81 6. Shiley Disposable Cannula, Fenestrated, Low Pressure, DFEN K843729, 10/19/84 Cuffed Tracheostomy Tube K865061, 1/15/87 7. Shiley Disposable Cannula, Cuffless Tracheostomy DCFS (non-fenestrated) K8…
Shiley, Inc.1984—
*K865061Shiley Dispos Cannula Fenes LP Cuffed Trache Tube
Summary page 1
…ula, Low Pressure, Cuffed Tracheostomy Tube DCT K811447, 6/26/81 6. Shiley Disposable Cannula, Fenestrated, Low Pressure, DFEN K843729, 10/19/84 Cuffed Tracheostomy Tube K865061, 1/15/87 7. Shiley Disposable Cannula, Cuffless Tracheostomy DCFS (non-fenestrated) K880614, 3/9/88 Tubes DCFEN (fenestrated) 8.…
Shiley, Inc.1987—
*K880614Shiley Disp. Cannula Cuffless Traceostomy Tube
Summary page 1
…a, Fenestrated, Low Pressure, DFEN K843729, 10/19/84 Cuffed Tracheostomy Tube K865061, 1/15/87 7. Shiley Disposable Cannula, Cuffless Tracheostomy DCFS (non-fenestrated) K880614, 3/9/88 Tubes DCFEN (fenestrated) 8. Shiley Pediatric/Neonatal Tracheal Tubes PED K945513, 1/13/95 NEO 9. Shiley Single Cannula T…
Shiley, Inc.1988—
*K945513Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube
Summary page 1
…5/87 7. Shiley Disposable Cannula, Cuffless Tracheostomy DCFS (non-fenestrated) K880614, 3/9/88 Tubes DCFEN (fenestrated) 8. Shiley Pediatric/Neonatal Tracheal Tubes PED K945513, 1/13/95 NEO 9. Shiley Single Cannula Tracheostomy Tube SCT K810106, 2/2/81 C:\Winword\Consult\Mallinkr\5 10ksumm.Doc === Page…
Mallinckrodt Medical19951
*K810106Shiley Single Cannula Tracheostomy Tube
Summary page 1
…enestrated) K880614, 3/9/88 Tubes DCFEN (fenestrated) 8. Shiley Pediatric/Neonatal Tracheal Tubes PED K945513, 1/13/95 NEO 9. Shiley Single Cannula Tracheostomy Tube SCT K810106, 2/2/81 C:\Winword\Consult\Mallinkr\5 10ksumm.Doc Appendix E Page 2 of 3 Device Description: These devices are…
Shiley, Inc.19816
*—Shiley Cuffless Tracheostomy Tubes
Named without a submission number
—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult… Class ICovidien20153
K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult… Class ICovidien20151
K062104Talking TrachEngineered Medical Systems, Inc.20070
K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc.20030
K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970

Has anything in its family been recalled? (3 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 18, 2012Class IZ-2174-2012Device DesignCovidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.
Apr 13, 2010Not classifiedZ-1473-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1468-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1491-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1489-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1464-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1462-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1480-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1466-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1465-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1476-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1481-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1472-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1477-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1467-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1490-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1463-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1478-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1470-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1479-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1469-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1488-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Apr 13, 2010Not classifiedZ-1471-2010Process designInflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

The 5 latest of 23 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.

  • K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible…Covidien · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy…Covidien · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K142296 (Covidien, 2015) has gone furthest, with 3 descendants of its own.

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 intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.

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

More from Mallinckrodt Medical

43 FDA decisions under this applicant name. See the company

  • K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 20082 recalls
  • K051416Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaMallinckrodt Medical · 2005
  • 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

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/K962173 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962173: Shikey Tracheostomy Tubes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962173

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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