510(k) Report

510(k) · Cleared

Cleared

Disposable Cannula Tracheostomy Tube, with Inner Cannula;Disposable Cannula Fenestrated Tracheostomy Tube, with Inner CN

K970811510(k) TraditionalCleared Nov 13, 1998618-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

Pneumocare, Inc. · JOH Tube Tracheostomy And Tube Cuff

Cleared on Nov 13, 1998 as substantially equivalent to K811447 (Shiley, Inc., 1981) and 1 other predicate after a 618-day review. Its family tree reaches back 1 generation to 1981.

Decided
Nov 13, 1998
Review
618 days
Class
Class II
Product code
JOH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K811447 (1981). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1990: 1 other ancestorK811447 · Shiley Disposable Cannula Trach. Tube · Shiley, Inc. · 198119801985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K811447 · Shiley Disposable Cannula Trach. Tube · Shiley, Inc. · 19810
  1. Root · 1 generation backK811447 Shiley Disposable Cannula Trach. TubeShiley, Inc. · 1981
  2. This deviceK970811 Disposable Cannula Tracheostomy Tube, with Inner Cannula;Disposable…Pneumocare, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K811447Shiley Disposable Cannula Trach. TubeShiley, Inc.1981—
0 (this device)K970811Disposable Cannula Tracheostomy Tube, with Inner Cannula;Disposable Cannula…Pneumocare, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
FIG. 1 — Lineage of K970811, 1981–1998Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K811447Shiley Disposable Cannula Trach. Tube
Summary page 1
…nestrated Tracheostomy Tube Tracheostomy Tube and Tube Cuff IDENTIFICATION OF PREDICATE DEVICE Company Device 310(k) No. Date Cleared Mallinckrodt Disposable Cannula K811447 June 26, 1981 Trach Tubes Concord Portex D.1.C. Tracheostomy K903730 September 25,1990 Tubes 13.4 13.5 13.6 D…
Shiley, Inc.1981—
*K903730D.I.C. Tracheostomy Tubes & Laryngectomy Tubes
Summary page 1
…CATION OF PREDICATE DEVICE Company Device 310(k) No. Date Cleared Mallinckrodt Disposable Cannula K811447 June 26, 1981 Trach Tubes Concord Portex D.1.C. Tracheostomy K903730 September 25,1990 Tubes 13.4 13.5 13.6 DEVICE DESCRIPTION The PneumoCare Disposable Cannula Tracheostomy Tube…
Concord/Portex1990—

Also cleared against K811447: 5 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 2 ancestors has a recall.
  • 5 other devices also cite its predicate K811447.

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 Disposable Cannula Tracheostomy Tubes are designed to provide an adult tracheostomy patient with an effective airway for breathing and/or ventilation.

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 K811447

5 other devices cite the same predicate.

  • K073702Phoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit ConnectorLazarus Medical, LLC · 2008
  • K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc. · 20031 recall
  • K963732Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner CannulaMallinckrodt Medical · 19972 recalls
  • K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 19961 Class I recall
  • K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996

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/K970811 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970811: Disposable Cannula Tracheostomy Tube, with Inner Cannula;Disposable Cannula Fenestrated Tracheostomy Tube, with Inner CN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970811

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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