Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sonic Incytes — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233977 | Velacur | Sonic Incytes | 2024-09-04 | 261 | 0 |
| K232459 | Velacur | Sonic Incytes | 2023-09-12 | 28 | 0 |
| K223287 | Velacur | Sonic Incytes | 2023-04-20 | 177 | 0 |
| K201597 | Liver Incytes, Model 1005 | Sonic Incytes | 2020-07-31 | 49 | 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