Somna Therapeutics, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Somna Therapeutics, LLC” (first 2018, latest 2018), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 108 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Somna Therapeutics, LLC took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKA | External Upper Esophageal Sphincter (Ues) Compression Device | 2 | 1 |
Review panels
Most recent Somna Therapeutics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173934 | Reza Band, Reflux Band | PKA | 2018-04-13 | 108 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130046 | De Novo | External Upper Esophageal Sphincter (Ues) Compression Device | 2015-03-06 |
Recalls
openFDA lists no recalls under a recalling firm named Somna Therapeutics, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Somna Therapeutics, LLC?
FDA lists 1 510(k) clearance under the applicant name “Somna Therapeutics, LLC” (first 2018, latest 2018), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Somna Therapeutics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somna Therapeutics, LLC is 108 days.
Which FDA product codes appear under Somna Therapeutics, LLC?
The most frequent FDA product codes under this applicant name are PKA (External Upper Esophageal Sphincter (Ues) Compression Device, 2).
Next steps
- See all 1 Somna Therapeutics, LLC clearances with predicates and recalls
- Run predicate analysis for product code PKA, Somna Therapeutics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.