510(k) · Cleared
ClearedProTrach Dualcare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atos Medical AB · JOH Tube Tracheostomy And Tube Cuff
Cleared on Feb 12, 2016 as substantially equivalent to K122932 (Fogless International AB, 2013) after a 262-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Feb 12, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122932 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK122932 Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without…Fogless International AB · 2013
- This deviceK151404 ProTrach DualcareAtos Medical AB · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122932 | Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen Port | Fogless International AB | 2013 | — |
| 0 (this device) | K151404 | ProTrach Dualcare | Atos Medical AB | 2016 | — |
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 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 |
|---|---|---|---|
| * | K122932 | Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen PortSummary page 4…H – Tracheotomy Tube and Tube Cuff Device: ProTrach DualCare Predicate Devices: Fogless International AB - SPIRO Speaking Valve – (K122932) Passy-Muir Inc.- Passy Muir Speaking Valves – (K944451) (for reference)… | 2013 |
| † | K944451 | Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves) | 1995 |
| † | K013728 | Trach Vox | 2002 |
| † | K022125 | Provox Freehands Hme, Model 7710 | 2002 |
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?
- Its one ancestor has no 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. 2016, 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?
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech. The entire device is for…
Read the full statement (121 words)
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.
The entire device is for single patient use and the HME-part is for single use.
Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
Environment of Use: Hospitals, ICU, sub-acute care institutions and home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151404: ProTrach Dualcare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151404
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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