Arineta , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Arineta , Ltd.” (first 2016, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 245 days. Since 2017 the median was 252 days, against 126 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 |
|---|---|---|
| 2016 | 1 | 117 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 400 |
| 2023 | 1 | 245 |
| 2024 | 0 | — |
| 2025 | 2 | 150 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arineta , Ltd. took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
Review panels
- Radiology (5)
Most recent Arineta , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | JAK | 2025-04-15 | 42 |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | JAK | 2025-01-13 | 258 |
| K230370 | SpotLight/SpotLight Duo (with DLIR option) | JAK | 2023-10-13 | 245 |
| K213465 | CardioGraphe | JAK | 2022-12-02 | 400 |
| K161066 | SpotLight CT | JAK | 2016-08-10 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Arineta , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arineta , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Arineta , Ltd.” (first 2016, latest 2025), across 1 product code 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 Arineta , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arineta , Ltd. is 245 days. Since 2017: 252 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arineta , Ltd.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 5).
Next steps
- See all 5 Arineta , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Arineta , Ltd.'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.