510(k) · Cleared
ClearedTrach Vox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jul 30, 2002 as substantially equivalent to K821568 (Bivona Medical Technologies, 1982) and 4 other predicates after a 263-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Jul 30, 2002
- Review
- 263 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K811241 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK811241 Bodai Suction -Safe 4Sontek Industries, Inc. · 1981
- This deviceK013728 Trach VoxEngineered Medical Systems · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811241 | Bodai Suction -Safe 4 | Sontek Industries, Inc. | 1981 | — |
| 0 (this device) | K013728 | Trach Vox | Engineered Medical Systems | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K821568 | Blow-Singer Tracheostoma ValveSummary page 1…(Taub) Prosthesis - Accessory Predicate Devices: In Health - Blom-Singer Tracheostorna with HumidiFilter Cap - K821568 Passy Muir Speaking Valves - K94445 1 Gibeck, Inc. - Trac… | 1982 |
| * | K944451 | Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves)Summary page 1…lth - Blom-Singer Tracheostorna with HumidiFilter Cap - K821568 Passy Muir Speaking Valves - K94445 1 Gibeck, Inc. - Trach-Vent - K952845 Vital Signs -Breathe… | 1995 |
| * | K952845 | Humid-Vent Trach-VentSummary page 1…HumidiFilter Cap - K821568 Passy Muir Speaking Valves - K94445 1 Gibeck, Inc. - Trach-Vent - K952845 Vital Signs -Breathe Easy - K914336 Intersurgical - Hydro… | 1995 |
| * | K914336 | Breathe EasySummary page 1…y Muir Speaking Valves - K94445 1 Gibeck, Inc. - Trach-Vent - K952845 Vital Signs -Breathe Easy - K914336 Intersurgical - Hydro-Trach T - exempt B&B Technologies -… | 1992 |
| * | K811241 | Bodai Suction -Safe 4Summary page 1…the Easy - K914336 Intersurgical - Hydro-Trach T - exempt B&B Technologies - Bodai Suction Safe - K811241 (DeviceDescription: I The TrachVox con… | 1981 |
| * | — | Intersurgical - Hydro-Trach T Named without a submission number |
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?
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K821568.
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?
For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.
For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013728: Trach Vox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013728
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026