# DEN130046: Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device

- Pathway: De Novo (Direct)
- Applicant: Somna Therapeutics, LLC
- Decided: Mar 6, 2015 after 477 days
- Product code: PKA (External Upper Esophageal Sphincter (Ues) Compression Device)
- Device class: 2
- Regulation: 21 CFR 874.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K173934: Reza Band, Reflux Band (2018), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/DEN130046
Methodology: https://510kreport.com/methodology