Nox Medical Ehf: FDA clearances and approvals
Nox Medical Ehf has 5 FDA 510(k) clearances (first 2015, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 169 days. Since 2017 its median was 172 days, against 183 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 169 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 230 |
| 2025 | 2 | 184 |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, Nox Medical Ehf's cleared 510(k)s took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Neurology (4)
- Anesthesiology (1)
Most recent Nox Medical Ehf 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260585 | Noxturnal Web | OLV | 2026-03-20 | 28 |
| K252330 | DeepRESP | OLZ | 2025-11-17 | 115 |
| K241960 | DeepRESP | OLZ | 2025-03-14 | 254 |
| K241288 | Noxturnal Web | OLV | 2024-12-23 | 230 |
| K151361 | Nox RIP Belts & Cables | MNR | 2015-11-06 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Nox Medical Ehf.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Nox Medical Ehf have?
Nox Medical Ehf has 5 FDA 510(k) clearances (first 2015, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Nox Medical Ehf's 510(k)s?
The median time from FDA receipt to decision across Nox Medical Ehf's cleared 510(k)s is 169 days. Since 2017: 172 days, versus 183 days for all cleared 510(k)s in the same product codes.
What devices does Nox Medical Ehf make?
Its most frequent FDA product codes are OLV (Standard Polysomnograph With Electroencephalograph, 2); OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph, 2); MNR (Ventilatory Effort Recorder, 1).
Has Nox Medical Ehf had device recalls?
openFDA lists no recalls under a recalling firm name matching Nox Medical Ehf. Related entities may recall under other names.
Next steps
- See all 5 Nox Medical Ehf clearances with predicates and recalls
- Run predicate analysis for product code OLV, Nox Medical Ehf's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.