510(k) · Cleared
ClearedTracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/SO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tracoe Medical GmbH · JOH Tube Tracheostomy And Tube Cuff
Cleared on Feb 18, 2005 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK043160 Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon…Tracoe Medical GmbH · 2005
- Descendant · cites it directly · 2 of its ownK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
- Descendant · 2 generations on · 1 of its ownK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
Most influential descendants
Showing 3 of 3 · See all- K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · cites it directly2descendants
- K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013 · 2 generations on1descendant
- K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043160 | Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist… | Tracoe Medical GmbH | 2005 | — |
| +1 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| +2 | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +3 | K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120079 | Primed Tracheostomy Tubes (Multiple) | 2012 | 2 |
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?
- Of its descendants, K120079 (Primed Halberstadt Medizintechnik GmbH, 2012) has gone furthest, with 2 descendants of its own.
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 Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with and without a supplementary oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the outer aspect of a tracheostomy tube with a 15mm standard connector (Phon Assist I- Model 650-T/TO) or a Tracoe Stoma Button (Phon Assist I- Model 650-S/SO). Both valves…
Read the full statement (168 words)
The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with and without a supplementary oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the outer aspect of a tracheostomy tube with a 15mm standard connector (Phon Assist I- Model 650-T/TO) or a Tracoe Stoma Button (Phon Assist I- Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane which allows air to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth.
The Phon Assist I (Ref Model 650-T/TO) Speaking Valves are indicated for uncuffed tracheostomy patients, cuffed tubes that have been fenestrated or deflated and Tracoe Stoma Buttons (Ref Model 650-S/SO) in the cases of:
Mild Tracheal Stenosis
Laryngeal Tumors
Bilateral Vocal Cord Paralysis
Trachealmalacia
Head Trauma
Broncheopulmonary Dysplasia
Amyotrophic Lateral Sclerosis
Chronic Obstructive Pulmonary Disease
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043160: Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/SO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043160
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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