Barosense, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Barosense, Inc.” (first 2009, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 237 days. 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 |
|---|---|---|
| 2012 | 2 | 134 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | 3 | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 2 |
Review panels
Most recent Barosense, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120126 | BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE | FED | 2012-09-10 | 237 |
| K120147 | ACE STAPLER AND CARTRIDGE | OCW | 2012-02-17 | 30 |
| K110829 | ACE STAPLER AND CARTRIDGE | OCW | 2011-06-03 | 71 |
| K082044 | ACE STAPLER, MODEL F0031 | OCW | 2010-05-11 | 662 |
| K082589 | BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 | FED | 2009-05-22 | 256 |
Recalls
openFDA lists no recalls under a recalling firm named Barosense, 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 Barosense, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00707720: Multi-Center Feasibility Study of Trans-oral Endoscopic Restrictive Implant System (TERIS) for Treatment of Obesity (Completed, started 2008-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Barosense, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Barosense, Inc.” (first 2009, latest 2012), 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 Barosense, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barosense, Inc. is 237 days.
Which FDA product codes appear under Barosense, Inc.?
The most frequent FDA product codes under this applicant name are OCW (Endoscopic Tissue Approximation Device, 3); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 2).
Next steps
- See all 5 Barosense, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCW, Barosense, 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.