Baronova, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Baronova, Inc.” (first 2018, latest 2019), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 101 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 |
|---|---|---|
| 2018 | 1 | 143 |
| 2019 | 2 | 60 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Baronova, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| LTI | Implant, Intragastric For Morbid Obesity | 1 | 0 |
| QGG | Esophageal Sheath With Distal Balloon Anchor | 1 | 1 |
Review panels
Most recent Baronova, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191078 | BAROnova Access Sheath Kit | QGG | 2019-07-22 | 90 |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | FCX | 2019-05-14 | 29 |
| K172575 | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap | FED | 2018-01-18 | 143 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180024 | PMA | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device | 2019-04-16 |
Recalls
openFDA lists no recalls under a recalling firm named Baronova, 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.
Device clinical trials
An industry sponsor named Baronova, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02518685: ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss (Completed, started 2015-09)
- NCT01386905: A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (Completed, started 2011-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baronova, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Baronova, Inc.” (first 2018, latest 2019), plus 1 PMA decision, across 4 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 Baronova, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baronova, Inc. is 90 days. Since 2017: 90 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Baronova, Inc.?
The most frequent FDA product codes under this applicant name are FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope, 1); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1); LTI (Implant, Intragastric For Morbid Obesity, 1).
Next steps
- See all 3 Baronova, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FCX, Baronova, 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.