Meditrina, Inc.: FDA clearances and approvals
Meditrina, Inc. has 5 FDA 510(k) clearances (first 2019, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time: 136 days. Since 2017 its median was 136 days, against 132 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 3 | 90 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 240 |
| 2023 | 1 | 244 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Meditrina, Inc.'s cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 5 | 5 |
Review panels
Most recent Meditrina, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223813 | Aveta System 2.0 | HIH | 2023-08-21 | 244 |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | HIH | 2022-05-26 | 240 |
| K192100 | Aveta Disposable Hysteroscope | HIH | 2019-12-19 | 136 |
| K191958 | Aveta System | HIH | 2019-10-01 | 70 |
| K190372 | Aveta System | HIH | 2019-05-16 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Meditrina, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Meditrina, Inc. have?
Meditrina, Inc. has 5 FDA 510(k) clearances (first 2019, latest 2023), across 1 product code in 1 review panel.
How long does FDA take to clear Meditrina, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Meditrina, Inc.'s cleared 510(k)s is 136 days. Since 2017: 136 days, versus 132 days for all cleared 510(k)s in the same product codes.
What devices does Meditrina, Inc. make?
Its most frequent FDA product codes are HIH (Hysteroscope (And Accessories), 5).
Has Meditrina, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Meditrina, Inc. Related entities may recall under other names.
Next steps
- See all 5 Meditrina, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIH, Meditrina, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.