Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arineta , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
245 daysmedian FDA review time
400 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screenin | Arineta , Ltd. | 2025-04-15 | 42 | 0 |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening | Arineta , Ltd. | 2025-01-13 | 258 | 0 |
| K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta , Ltd. | 2023-10-13 | 245 | 0 |
| K213465 | CardioGraphe | Arineta , Ltd. | 2022-12-02 | 400 | 0 |
| K161066 | SpotLight CT | Arineta , Ltd. | 2016-08-10 | 117 | 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