510(k) · Cleared
ClearedPassy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) Jit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Passy-Muir, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jun 11, 1999 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 11, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians…
Read the full statement (178 words)
The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.
For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake
Bilateral Vocal Cord Paralysis without significant airway obstruction
Tracheomalacia
Mild Tracheal and Laryngeal Stenosis
Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following surgical resection of the tumor)
Neuromuscular Disease
Chronic Obstructive Pulmonary Disease
Brain Injury
Non-Ventilator Dependent Quadriplegics
Patients who emotionally or physically are unable to tolerate plugging
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990905 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990905: Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) Jit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026