Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baronova, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191078 | BAROnova Access Sheath Kit | Baronova, Inc. | 2019-07-22 | 90 | 0 |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019-05-14 | 29 | 0 |
| K172575 | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscop | Baronova, Inc. | 2018-01-18 | 143 | 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