Rivanna Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Rivanna Medical, Inc.” (first 2014, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 142 days. Since 2017 the median was 130 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 |
|---|---|---|
| 2014 | 1 | 189 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 142 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 134 |
| 2026 | 3 | 119 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rivanna Medical, Inc. took a median 130 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
Review panels
- Radiology (7)
Most recent Rivanna Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261014 | Accuro® 3S Needle Guide Kit | ITX | 2026-07-24 | 119 |
| K253452 | Accuro 3S | IYO | 2026-07-24 | 291 |
| K254021 | Accuro XV | IYO | 2026-04-09 | 114 |
| K250469 | Accuro® 3S Needle Guide Kit | ITX | 2025-06-13 | 115 |
| K243937 | Accuro 3S | IYO | 2025-05-23 | 154 |
| K171594 | Accuro | IYO | 2017-10-20 | 142 |
| K132736 | ACCURO 3000 ULTRASOUND SCANNER | IYO | 2014-03-11 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Rivanna Medical, Inc..
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 Rivanna Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Rivanna Medical, Inc.” (first 2014, latest 2026), across 2 product codes 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 Rivanna Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rivanna Medical, Inc. is 142 days. Since 2017: 130 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rivanna Medical, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 7 Rivanna Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Rivanna Medical, Inc.'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.