Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avicenna.Ai — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
168 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240942 | CINA-CSpine | Avicenna.Ai | 2024-09-12 | 160 | 0 |
| K240612 | CINA-VCF | Avicenna.Ai | 2024-05-31 | 87 | 0 |
| K233342 | CINA-ASPECTS | Avicenna.Ai | 2024-03-15 | 168 | 0 |
| K233968 | CINA-iPE | Avicenna.Ai | 2024-03-13 | 89 | 0 |
| K221716 | CINA | Avicenna.Ai | 2022-11-22 | 162 | 0 |
| K210237 | CINA CHEST | Avicenna.Ai | 2021-05-19 | 111 | 0 |
| K200855 | CINA | Avicenna.Ai | 2020-06-24 | 85 | 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