Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rivanna Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
291 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 | 119 | 0 |
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 | 291 | 0 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 | 114 | 0 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 | 115 | 0 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 | 154 | 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