Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meditrina, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
244 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023-08-21 | 244 | 0 |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Cora | Meditrina, Inc. | 2022-05-26 | 240 | 0 |
| K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | 2019-12-19 | 136 | 0 |
| K191958 | Aveta System | Meditrina, Inc. | 2019-10-01 | 70 | 0 |
| K190372 | Aveta System | Meditrina, Inc. | 2019-05-16 | 90 | 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