510(k) · Cleared
Recalled · Class III · 2013Blow-Singer Tracheostoma Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bivona Medical Technologies · EWL Prosthesis, Laryngeal (Taub)
Cleared on Jul 26, 1982 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 26, 1982
- Review
- 60 days
- Class
- Class II
- Product code
- EWL
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK821568 Blow-Singer Tracheostoma ValveBivona Medical Technologies · 1982
- Descendant · cites it directly · 2 of its ownK022125 Provox Freehands Hme, Model 7710Atos Medical AB · 2002
- Descendant · 2 generations on · 0 of its ownK141380 Provox Freehands FlexivoiceAtos Medical AB · 2014
- Descendant · 2 generations on · 0 of its ownK072582 Provox Micron HmeAtos Medical AB · 2008
- Descendant · cites it directly · 0 of its ownK043138 Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134Atos Medical AB · 2004
- Descendant · cites it directly · 0 of its ownK013728 Trach VoxEngineered Medical Systems · 2002
Most influential descendants
Showing 5 of 5 · See all- K022125Provox Freehands Hme, Model 7710Atos Medical AB · 2002 · cites it directly2descendants
- K141380Provox Freehands FlexivoiceAtos Medical AB · 2014 · 2 generations on0descendants
- K072582Provox Micron HmeAtos Medical AB · 2008 · 2 generations on0descendants
- K043138Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134Atos Medical AB · 2004 · cites it directly0descendants
- K013728Trach VoxEngineered Medical Systems · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821568 | Blow-Singer Tracheostoma Valve | Bivona Medical Technologies | 1982 | — |
| +1 | K022125 | Provox Freehands Hme, Model 7710 | Atos Medical AB | 2002 | — |
| +2 | K141380 | Provox Freehands Flexivoice | Atos Medical AB | 2014 | — |
| +2 | K072582 | Provox Micron Hme | Atos Medical AB | 2008 | — |
| +1 | K043138 | Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134 | Atos Medical AB | 2004 | — |
| +1 | K013728 | Trach Vox | Engineered Medical Systems | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWL? 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 EWL device
- #1 K240763 FirstFit Surgical Kitscore 9.1 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2013 | Class III | Z-0128-2014 | Packaging change control | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022125 (Atos Medical AB, 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EWL devicesEWL Prosthesis, Laryngeal (Taub): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWL
Too few EWL 510(k)s in any year since 2007 to give a median.
Recalls per year · EWL
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWL
12in 2025
MAUDE reports naming product code EWL, 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 | 0 | — | 0 | 21 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 5 |
| 2014 | 1 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K821568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821568: Blow-Singer Tracheostoma Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821568
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026