510(k) Report

510(k) · Cleared

Cleared

Tracheostomy Tubes Tracoe-Flex

K961449510(k) TraditionalCleared Sep 13, 1996150-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

Tracoe Medical GmbH · JOH Tube Tracheostomy And Tube Cuff

Cleared on Sep 13, 1996 as substantially equivalent to K811033 (Shiley, Inc., 1981) and 13 other predicates after a 150-day review. Its family tree reaches back 1 generation to 1978. 3 later devices descend from it.

Decided
Sep 13, 1996
Review
150 days
Class
Class II
Product code
JOH
Recalls
None
Predicates
14

Its longest line of descent runs back 1 generation to K781729 (1978). 14 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor1982: 1 other ancestor1981: 4 other ancestors2012: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant clearedK781729 · Tracheotomy Tubes · Tracoe Medical GmbH · 197819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 13 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K781729 · Tracheotomy Tubes · Tracoe Medical GmbH · 19780
  1. Root · 1 generation backK781729 Tracheotomy TubesTracoe Medical GmbH · 1978
  2. This deviceK961449 Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996
  3. Descendant · cites it directly · 2 of its ownK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
  4. Descendant · cites it directly · 1 of its ownK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
  5. Descendant · 2 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · cites it directly2descendants
  • K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013 · cites it directly1descendant
  • K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K781729Tracheotomy TubesTracoe Medical GmbH1978—
0 (this device)K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH1996—
+1K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH2012—
+1K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH2013—
+2K233713Pilling Tracheostomy TubesTeleflex Medical2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198140
198210
198510
198610
198710
198810
198910
199010
199110
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
202410
FIG. 1 — Lineage of K961449, 1978–2024Source: 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? (14)

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
*K811033Shiley Low Pressure Thin-Cuffed Trach
Summary page 3
…EX model 302 and 304. 4. Predicate Devices: TRACOE*-FLEX Predicate devices 510(K) Number Model 301 - Shiley Low Pressure Thin Cuffed Tracheostomy Tube, Non-Fenestrated K811033 - Modified Shiley Low Pressure Cuffed Tracheostomy Tube K880614 - Bivona Aire Cuff Silicone Tracheostomy Tube K885130 - Fome-Cu…
Shiley, Inc.1981—
*K880614Shiley Disp. Cannula Cuffless Traceostomy Tube
Summary page 3
…te devices 510(K) Number Model 301 - Shiley Low Pressure Thin Cuffed Tracheostomy Tube, Non-Fenestrated K811033 - Modified Shiley Low Pressure Cuffed Tracheostomy Tube K880614 - Bivona Aire Cuff Silicone Tracheostomy Tube K885130 - Fome-Cuf and Aire-Cuf Tracheostomy Tubes (Shapiro-Bivona) K862267 - Por…
Shiley, Inc.1988—
*K885130Modified Aire-Cuf Silicone Tracheostomy Tube
Summary page 3
…e Thin Cuffed Tracheostomy Tube, Non-Fenestrated K811033 - Modified Shiley Low Pressure Cuffed Tracheostomy Tube K880614 - Bivona Aire Cuff Silicone Tracheostomy Tube K885130 - Fome-Cuf and Aire-Cuf Tracheostomy Tubes (Shapiro-Bivona) K862267 - Portex Tracheostomy Tubes with Cuff K903730 Summary Page…
Bivona Medical Technologies1989—
*K862267Fome-Cuf and Aire Cuf Tracheostomy Tubes
Summary page 3
…Shiley Low Pressure Cuffed Tracheostomy Tube K880614 - Bivona Aire Cuff Silicone Tracheostomy Tube K885130 - Fome-Cuf and Aire-Cuf Tracheostomy Tubes (Shapiro-Bivona) K862267 - Portex Tracheostomy Tubes with Cuff K903730 Summary Page 3 Model 302 Model 303 Model 304 Model 305 Model 4…
Bivona Medical Technologies1986—
*K903730D.I.C. Tracheostomy Tubes & Laryngectomy Tubes
Summary page 3
…880614 - Bivona Aire Cuff Silicone Tracheostomy Tube K885130 - Fome-Cuf and Aire-Cuf Tracheostomy Tubes (Shapiro-Bivona) K862267 - Portex Tracheostomy Tubes with Cuff K903730 Summary Page 3 Model 302 Model 303 Model 304 Model 305 Model 401 - Shiley Fenestrated Low Pressure Cuffed T…
Concord/Portex1990—
*K812302Shiley Fenestrated Low Press. Cuffed
Summary page 4
…730 Summary Page 3 Model 302 Model 303 Model 304 Model 305 Model 401 - Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Improved Cuff K812302 - Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube K865061 - Shiley Single Cannula Tracheostomy Tub…
Shiley, Inc.19811
*K865061Shiley Dispos Cannula Fenes LP Cuffed Trache Tube
Summary page 4
…- Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Improved Cuff K812302 - Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube K865061 - Shiley Single Cannula Tracheostomy Tube K810106 - Shiley Disposable Cannula Tracheo- stomy Tube K811447 - Portex Tracheostomy…
Shiley, Inc.1987—
*K810106Shiley Single Cannula Tracheostomy Tube
Summary page 4
…stomy Tube with Improved Cuff K812302 - Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube K865061 - Shiley Single Cannula Tracheostomy Tube K810106 - Shiley Disposable Cannula Tracheo- stomy Tube K811447 - Portex Tracheostomy Tubes without Cuff K912124 - Tracoe Tracheostomy…
Shiley, Inc.19816
*K811447Shiley Disposable Cannula Trach. Tube
Summary page 4
…e Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube K865061 - Shiley Single Cannula Tracheostomy Tube K810106 - Shiley Disposable Cannula Tracheo- stomy Tube K811447 - Portex Tracheostomy Tubes without Cuff K912124 - Tracoe Tracheostomy Tubes K781729 - Shiley Cuffless Fenestrated Tracheostomy…
Shiley, Inc.1981—
*K912124Tracheostomy Tube and Cuff
Summary page 4
…ostomy Tube K865061 - Shiley Single Cannula Tracheostomy Tube K810106 - Shiley Disposable Cannula Tracheo- stomy Tube K811447 - Portex Tracheostomy Tubes without Cuff K912124 - Tracoe Tracheostomy Tubes K781729 - Shiley Cuffless Fenestrated Tracheostomy Tube K880614 - Shiley Laryngectomy Tube K821993 -…
Concord/Portex1991—
*K781729Tracheotomy Tubes
Summary page 4
…Cannula Tracheostomy Tube K810106 - Shiley Disposable Cannula Tracheo- stomy Tube K811447 - Portex Tracheostomy Tubes without Cuff K912124 - Tracoe Tracheostomy Tubes K781729 - Shiley Cuffless Fenestrated Tracheostomy Tube K880614 - Shiley Laryngectomy Tube K821993 - Shiley Phonate Speaking Valve K9454…
Tracoe Medical GmbH1978—
*K821993Shiley Laryngectomy Tube
Summary page 4
…- Portex Tracheostomy Tubes without Cuff K912124 - Tracoe Tracheostomy Tubes K781729 - Shiley Cuffless Fenestrated Tracheostomy Tube K880614 - Shiley Laryngectomy Tube K821993 - Shiley Phonate Speaking Valve K945406 - Bivona Tracheostomy Valve K852272 - Tracoe Tracheostomy Tubes with Speaking Valve K781…
Shiley, Inc.1982—
*K945406SSV Phonate (TM) Shiley Speaking Valve
Summary page 4
…f K912124 - Tracoe Tracheostomy Tubes K781729 - Shiley Cuffless Fenestrated Tracheostomy Tube K880614 - Shiley Laryngectomy Tube K821993 - Shiley Phonate Speaking Valve K945406 - Bivona Tracheostomy Valve K852272 - Tracoe Tracheostomy Tubes with Speaking Valve K781729 Technological Characteristics of TR…
Mallinckrodt Medical Tpi, Inc.1995—
*K852272Bivona Tracheostoma Valve II
Summary page 4
…s K781729 - Shiley Cuffless Fenestrated Tracheostomy Tube K880614 - Shiley Laryngectomy Tube K821993 - Shiley Phonate Speaking Valve K945406 - Bivona Tracheostomy Valve K852272 - Tracoe Tracheostomy Tubes with Speaking Valve K781729 Technological Characteristics of TRACOE"-FLEX tubes compared to the Sh…
Bivona Medical Technologies1985—

Also cleared against K811033: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122
K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131

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?

  • 2 of the 14 ancestors have a recall of any class.
  • Of its descendants, K120079 (Primed Halberstadt Medizintechnik GmbH, 2012) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K811033.

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?

Model 301: device is intended for providing tracheal access for airway management including artificial ventilation. Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve". Model 303: device is intended for…

Read the full statement (164 words)

Model 301: device is intended for providing tracheal access for airway management including artificial ventilation.

Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve".

Model 303: device is intended for providing tracheal access for airway management.

Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve".

Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy

Model 401: device is intended for use in patients with the larynx intact in combination with TRACOE®-FLEX model 302 and 304.

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 K811033

3 other devices cite the same predicate.

  • K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
  • K030381Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex, Ltd. · 20032 recalls
  • K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 19961 Class I recall

More from Tracoe Medical GmbH

8 FDA decisions under this applicant name. See the company

  • K203362TRACOE varioTracoe Medical GmbH · 2021
  • K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH · 2018
  • K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbH · 2016
  • K152865TRACOE smart Cuff ManagerTracoe Medical GmbH · 2016
  • K051587Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470Tracoe Medical GmbH · 2005

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/K961449 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961449: Tracheostomy Tubes Tracoe-Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961449

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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