Somnomed, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Somnomed, Inc.” (first 2005, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 147 days, against 170 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2012 | 1 | 27 |
| 2013 | 1 | 74 |
| 2014 | 1 | 137 |
| 2015 | 1 | 125 |
| 2016 | 1 | 34 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 147 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 338 |
| 2025 | 0 | — |
| 2026 | 1 | 46 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Somnomed, Inc. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 170 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRK | Device, Anti-Snoring | 9 | 9 |
| PLC | Sleep Appliances With Patient Monitoring | 2 | 2 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (12)
Most recent Somnomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261366 | Virtus | LRK | 2026-06-12 | 46 |
| K233497 | Rest Assure System | PLC | 2024-10-03 | 338 |
| K183443 | SomnoDent Avant | LRK | 2019-05-08 | 147 |
| K162306 | SomnoDent ALPHA | LRK | 2016-09-20 | 34 |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder | PLC | 2015-06-18 | 125 |
| K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | LRK | 2014-06-20 | 137 |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEX | LRK | 2013-05-17 | 74 |
| K121340 | SOMNODENT G2 | LRK | 2012-05-30 | 27 |
| K102909 | SOMNOBRUX SPLINTS | MQC | 2011-12-13 | 438 |
| K102521 | PANTINO PRO POSITINER | LRK | 2011-03-28 | 207 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Somnomed, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Somnomed Technologies Inc., Doing Business AS Remware (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Somnomed, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Somnomed, Inc.” (first 2005, latest 2026), across 3 product codes 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 Somnomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somnomed, Inc. is 126 days. Since 2017: 147 days, versus 170 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Somnomed, Inc.?
The most frequent FDA product codes under this applicant name are LRK (Device, Anti-Snoring, 9); PLC (Sleep Appliances With Patient Monitoring, 2); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 12 Somnomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRK, Somnomed, Inc.'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.