Oxos Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Oxos Medical, Inc.” (first 2021, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 165 days. Since 2017 the median was 165 days, against 100 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 |
|---|---|---|
| 2021 | 2 | 26 |
| 2022 | 1 | 165 |
| 2023 | 0 | — |
| 2024 | 1 | 189 |
| 2025 | 1 | 174 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oxos Medical, Inc. took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 2 |
Review panels
- Radiology (5)
Most recent Oxos Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252068 | MC2 Portable X-ray System | OWB | 2025-12-22 | 174 |
| K241567 | MC2 Portable X-ray System | OWB | 2024-12-06 | 189 |
| K212654 | Micro C Medical Imaging System, M01 | IZL | 2022-02-04 | 165 |
| K211473 | Micro C Medical Imaging System, M01 | IZL | 2021-06-04 | 23 |
| K203658 | Micro C Medical Imaging System, M01 | IZL | 2021-01-12 | 28 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-06-11.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Oxos Medical, Inc. (3)
- Oxos Medical (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oxos Medical, Inc.?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Oxos Medical, Inc.” (first 2021, latest 2025), across 2 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 Oxos Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxos Medical, Inc. is 165 days. Since 2017: 165 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Oxos Medical, Inc.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 3); OWB (Interventional Fluoroscopic X-Ray System, 2).
Next steps
- See all 5 Oxos Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Oxos Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.