De Novo · Granted
GrantedReza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somna Therapeutics, LLC · PKA External Upper Esophageal Sphincter (Ues) Compression Device
Granted on Mar 6, 2015 as a new device type through De Novo after a 477-day review. 1 later device descends from it.
- Decided
- Mar 6, 2015
- Review
- 477 days
- Class
- Class II
- Product code
- PKA
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN130046 Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist DeviceSomna Therapeutics, LLC · 2015
- Descendant · cites it directly · 0 of its ownK173934 Reza Band, Reflux BandSomna Therapeutics, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K173934Reza Band, Reflux BandSomna Therapeutics, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130046 | Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device | Somna Therapeutics, LLC | 2015 | — |
| +1 | K173934 | Reza Band, Reflux Band | Somna Therapeutics, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA De Novo 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 PKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173934 | Reza Band, Reflux Band | 2018 | 0 |
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, K173934 (Somna Therapeutics, LLC, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PKA devicesPKA External Upper Esophageal Sphincter (Ues) Compression Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PKA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PKA
Too few PKA 510(k)s in any year since 2007 to give a median.
Recalls per year · PKA
No recall names PKA since 2007.
Adverse event reports per year · PKA
No MAUDE report names PKA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
patients 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The device is worn by the patient when sleeping
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130046 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130046: Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130046
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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