510(k) Report

510(k) · Cleared

Cleared

Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal Extension, Cuf

K971267510(k) TraditionalCleared Sep 25, 1997174-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 Sep 25, 1997 as substantially equivalent to K890194 (Shiley, Inc., 1989) and 6 other predicates after a 174-day review. Its family tree reaches back 2 generations to 1979. 1 of the 17 devices in its family, counting itself, has a Class I recall.

Decided
Sep 25, 1997
Review
174 days
Class
Class II
Product code
JOH
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K792222 (1979). 16 ancestors in all. No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1991: 1 other ancestor1989: 1 other ancestor1987: 2 other ancestors1986: 2 other ancestors1981: 4 other ancestors1995: 1 other ancestor1988: 1 other ancestor1984: 1 other ancestor1982: 1 other ancestorK792222 · Shiley Low Pressure Thin-Cuffed Trach. · Shiley, Inc. · 1979K962173 · Shikey Tracheostomy Tubes and Accessories · Mallinckrodt Medical · 1996 · Class I recall19751980198519901995
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 8 other ancestors K962173 · Shikey Tracheostomy Tubes and Accessories · Mallinckrodt Medical · 1996 · Class I recallK792222 · Shiley Low Pressure Thin-Cuffed Trach. · Shiley, Inc. · 19790
  1. Root · 2 generations backK792222 Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc. · 1979
  2. 1 generation backK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Recalled (Class I)
  3. This deviceK971267 Shiley Extended Length, Disposable Cannula, Tracheostomy Tube…Mallinckrodt Medical · 1997

Class I recalls in this family

  • K962173 Shikey Tracheostomy Tubes and Accessoriesdirect predicate · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K792222Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc.1979—
−1K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical1996Class I
0 (this device)K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal…Mallinckrodt Medical1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198140
198210
198410
198620
198720
198810
198910
199110
199510
FIG. 1 — Lineage of K971267, 1979–1997Source: 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.

1 device in this family has 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? (8)

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
*K890194Shiley Specialized Tracheostomy Tube
Summary page 1
…the O/D size) (Mallinckrodt owns the U.S. patent). 2. Specialized Tracheostomy Tubes “MODIFIED xxx” (where xxx is the usual product designation of the modified tube) K890194A, 7/20/89 3. Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy DCT and DIC (standard Disposable Inner Cannula includ…
Shiley, Inc.1989—
*K962173Shikey Tracheostomy Tubes and Accessories
Summary page 1
…tube) K890194A, 7/20/89 3. Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy DCT and DIC (standard Disposable Inner Cannula included with DCT Tracheostomy K962173, 10/4/96 i Tracheostomy Tube Tube with Soft Swivel Neck Flange Tube) feature. 4. Shiley Sleep Apnea Cuffed and SLP (cuffed) K86…
Mallinckrodt Medical1996Class I
*K861463Shiley Sleep Apnea Low Pressure Cuffed Trach Tube
Summary page 1
…ula included with DCT Tracheostomy K962173, 10/4/96 i Tracheostomy Tube Tube with Soft Swivel Neck Flange Tube) feature. 4. Shiley Sleep Apnea Cuffed and SLP (cuffed) K861463, 5/6/86 Cuffless Tracheostomy Tubes SCS (cuffless) K861462, 5/6/86 5. Shiley Single Cannula SCT K810106, 2/2/81 C:\Winword\Consu…
Shiley, Inc.1986—
*K861462Shiley Sleep Apnea Cuffless Tracheostomy Tube
Summary page 1
…cheostomy Tube Tube with Soft Swivel Neck Flange Tube) feature. 4. Shiley Sleep Apnea Cuffed and SLP (cuffed) K861463, 5/6/86 Cuffless Tracheostomy Tubes SCS (cuffless) K861462, 5/6/86 5. Shiley Single Cannula SCT K810106, 2/2/81 C:\Winword\Consult\Mallinc\Xlc5 10k\Xlcsumm. Doc Appendix F…
Shiley, Inc.1986—
*K810106Shiley Single Cannula Tracheostomy Tube
Summary page 1
…ange Tube) feature. 4. Shiley Sleep Apnea Cuffed and SLP (cuffed) K861463, 5/6/86 Cuffless Tracheostomy Tubes SCS (cuffless) K861462, 5/6/86 5. Shiley Single Cannula SCT K810106, 2/2/81 C:\Winword\Consult\Mallinc\Xlc5 10k\Xlcsumm. Doc Appendix F Page 2 of 4 Predicate Device Names Product…
Shiley, Inc.19816
*K871204Cuffed Tracheal Tube (Multiple)
Summary page 2
…umm. Doc Appendix F Page 2 of 4 Predicate Device Names Product Designations 510(k) Number 6. Mallinckrodt Cuffed Tracheal Tube Hi-Lo Tracheal Tubes K871204, 4/21/87 7. Mallinckrodt Critical Care Broncho-Cath Right Endobronchial Tube with CPAP Valve 85815, 85816, 85817, and 85818 K9…
Mallinckrodt Critical Care19871
*K912240Cpap System and Broncho-Cath W/Cpap System
Our OCR of the scanned summary read K912230, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mallinckrodt Critical Care Broncho-Cath Right Endobronchial Tube…”.
Mallinckrodt Anesthesia Products1991—
*—Smiths Industries Medical Systems (SIMS), Profile Tracheostomy Tubes with Portex…
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

  • K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.8 years on median.
  • 5 of the 16 ancestors have a recall of any class; 1 has a Class I recall.

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?

To provide tracheal access 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.

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
  • 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/K971267 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971267: Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal Extension, Cuf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971267

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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