510(k) · Cleared
ClearedShikani-French Speaking Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pilling Weck Surgical · JOH Tube Tracheostomy And Tube Cuff
Cleared on Oct 23, 1998 as substantially equivalent to K944451 (Passy-Muir, Inc., 1995) and 1 other predicate after a 128-day review. Its family tree reaches back 3 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 23, 1998
- Review
- 128 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934465 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK934465 Dic Tracheostomy Tube and Portex Blue LineSmiths Industries Medical Systems, Inc. · 1994 · Recalled
- 2 generations backK955564 Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996
- 1 generation backK964056 Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch…Rusch Intl. · 1997 · Recalled (Class I)
- This deviceK982128 Shikani-French Speaking ValvePilling Weck Surgical · 1998
- Descendant · cites it directly · 0 of its ownK100995 Shikani Speaking ValveShikani Medical, LLC · 2010
Class I recalls in this family
- K964056 Rusch Ultra Tracheoflex Fenestrated Kit…direct predicate · 1997
Most influential descendants
Showing 1 of 1 · See all- K100995Shikani Speaking ValveShikani Medical, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934465 | Dic Tracheostomy Tube and Portex Blue Line | Smiths Industries Medical Systems, Inc. | 1994 | 2 |
| −2 | K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile | Rusch, Inc. | 1996 | — |
| −1 | K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex… | Rusch Intl. | 1997 | Class I |
| 0 (this device) | K982128 | Shikani-French Speaking Valve | Pilling Weck Surgical | 1998 | — |
| +1 | K100995 | Shikani Speaking Valve | Shikani Medical, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944451 | Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves)Summary page 2…racheostomized patient. Summary of Technological Characteristics. The technological characteristics are the same as, or equivalent to, predicate devices by Passy Muir (K944451), Willy Riisch (K964056), and A&M speaking valves. Prcez o HEALTH 4 C DEPARTMENT OF HEALTH & HUMAN SERVICES Pub… | 1995 |
| * | K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy…Summary page 2…Summary of Technological Characteristics. The technological characteristics are the same as, or equivalent to, predicate devices by Passy Muir (K944451), Willy Riisch (K964056), and A&M speaking valves. Prcez o HEALTH 4 C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 001… | 1997 |
| * | — | A&M speaking valve Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100995 | Shikani Speaking Valve | 2010 | 0 |
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.
- K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed SterileRusch Intl. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K100995 (Shikani Medical, LLC, 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K944451.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
To allow airflow over the vocal cords for speaking function. To be used only as an attachment to CLJackson improved trachea tubes, manufactured by Pilling Weck Surgical.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982128: Shikani-French Speaking Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982128
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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