510(k) · Cleared
ClearedReza Band, Reflux Band
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
Cleared on Apr 13, 2018 as substantially equivalent to DEN130046 (Somna Therapeutics, LLC, 2015) after a 108-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Apr 13, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- PKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130046 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130046 Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist DeviceSomna Therapeutics, LLC · 2015
- This deviceK173934 Reza Band, Reflux BandSomna Therapeutics, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130046 | Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device | Somna Therapeutics, LLC | 2015 | — |
| 0 (this device) | K173934 | Reza Band, Reflux Band | Somna Therapeutics, LLC | 2018 | — |
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 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
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 |
|---|---|---|---|
| * | DEN130046 | Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist DeviceSummary page 4…on device (21 Name: CFR 874.5900, Product Code PKA) Predicate Device: Reza Band ® Upper Esophageal Sphincter (UES) Assist Device (DEN130046) Device The Reza Band and Reflux Band are proposed for over the counter Description: (OTC) use.… | 2015 |
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 PKA devicesPKA External Upper Esophageal Sphincter (Ues) Compression Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Reza Band and the Reflux Band are for people 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 devices are worn by the user while sleeping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173934: Reza Band, Reflux Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173934
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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