510(k) · Cleared
ClearedShikani Speaking Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shikani Medical, LLC · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jun 25, 2010 as substantially equivalent to K982128 (Pilling Weck Surgical, 1998) after a 77-day review. Its family tree reaches back 4 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 25, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934465 (1994). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK934465 Dic Tracheostomy Tube and Portex Blue LineSmiths Industries Medical Systems, Inc. · 1994 · Recalled
- 3 generations backK955564 Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996
- 2 generations backK964056 Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch…Rusch Intl. · 1997 · Recalled (Class I)
- 1 generation backK982128 Shikani-French Speaking ValvePilling Weck Surgical · 1998
- This deviceK100995 Shikani Speaking ValveShikani Medical, LLC · 2010
Class I recalls in this family
- K964056 Rusch Ultra Tracheoflex Fenestrated Kit…2 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934465 | Dic Tracheostomy Tube and Portex Blue Line | Smiths Industries Medical Systems, Inc. | 1994 | 2 |
| −3 | K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile | Rusch, Inc. | 1996 | — |
| −2 | K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex… | Rusch Intl. | 1997 | Class I |
| −1 | K982128 | Shikani-French Speaking Valve | Pilling Weck Surgical | 1998 | — |
| 0 (this device) | K100995 | Shikani Speaking Valve | Shikani Medical, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (1)
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 |
|---|---|---|---|
| * | K982128 | Shikani-French Speaking ValveSummary page 1…JO -1-21 CFR 868.5800 Predicate Devices: Pilling Weck (Teleflex) - Shikani-French speaking valve K982 128 Device Description The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Onc… | 1998 |
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.
- K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed SterileRusch Intl. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
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. 2010, this device’s year, is highlighted.
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 with a standard 15 mm connection on tracheostomy tubes.
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/K100995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100995: Shikani Speaking Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100995
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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