Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Somnomed, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
338 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261366 | Virtus | Somnomed, Inc. | 2026-06-12 | 46 | 0 |
| K233497 | Rest Assure System | Somnomed, Inc. | 2024-10-03 | 338 | 0 |
| K183443 | SomnoDent Avant | Somnomed, Inc. | 2019-05-08 | 147 | 0 |
| K162306 | SomnoDent ALPHA | Somnomed, Inc. | 2016-09-20 | 34 | 0 |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent F | Somnomed, Inc. | 2015-06-18 | 125 | 0 |
| K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | Somnomed, Inc. | 2014-06-20 | 137 | 0 |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEX | Somnomed, Inc. | 2013-05-17 | 74 | 0 |
| K121340 | SOMNODENT G2 | Somnomed, Inc. | 2012-05-30 | 27 | 0 |
| K102909 | SOMNOBRUX SPLINTS | Somnomed, Inc. | 2011-12-13 | 438 | 0 |
| K102521 | PANTINO PRO POSITINER | Somnomed, Inc. | 2011-03-28 | 207 | 0 |
| K073004 | SOMNOMED BFLEX | Somnomed, Inc. | 2008-01-30 | 98 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda