Somnomedics GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Somnomedics GmbH” (first 2007, latest 2024), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 222 days. Since 2017 the median was 246 days, against 189 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 302 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 113 |
| 2021 | 0 | — |
| 2022 | 1 | 324 |
| 2023 | 1 | 222 |
| 2024 | 1 | 269 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Somnomedics GmbH took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 189 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 3 | 3 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
Review panels
- Anesthesiology (3)
- Neurology (3)
- Cardiovascular (1)
Most recent Somnomedics GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240700 | HomeSleepTest (HST, HST REM+) | OLV | 2024-12-08 | 269 |
| K231104 | ABPMpro | DSH | 2023-11-27 | 222 |
| K212325 | EEG-acp | GYB | 2022-06-15 | 324 |
| K201054 | SOMNOscreen plus | OLV | 2020-08-12 | 113 |
| K140861 | SOMNOTOUCH RESP | MNR | 2015-01-30 | 302 |
| K081485 | SOMNOWATCH | MNR | 2008-09-18 | 113 |
| K071556 | SOMNOSCREEN EEG10-20 | MNR | 2007-07-18 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Somnomedics GmbH.
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.
- Somnomedics GmbH & Co. KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Somnomedics GmbH?
FDA lists 7 510(k) clearances under the applicant name “Somnomedics GmbH” (first 2007, latest 2024), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Somnomedics GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somnomedics GmbH is 222 days. Since 2017: 246 days, versus 189 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Somnomedics GmbH?
The most frequent FDA product codes under this applicant name are MNR (Ventilatory Effort Recorder, 3); OLV (Standard Polysomnograph With Electroencephalograph, 2); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 7 Somnomedics GmbH clearances with predicates and recalls
- Run predicate analysis for product code MNR, Somnomedics GmbH'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.