Ninepoint Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ninepoint Medical, Inc.” (first 2011, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 56 days, against 88 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 |
|---|---|---|
| 2012 | 1 | 97 |
| 2013 | 1 | 405 |
| 2014 | 0 | — |
| 2015 | 1 | 44 |
| 2016 | 1 | 76 |
| 2017 | 0 | — |
| 2018 | 2 | 49 |
| 2019 | 1 | 84 |
| 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 Ninepoint Medical, Inc. took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 8 | 8 |
Review panels
Most recent Ninepoint Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191117 | NvisionVLE Low-profile Optical Probe | NQQ | 2019-07-19 | 84 |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | NQQ | 2018-11-02 | 42 |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | NQQ | 2018-10-16 | 56 |
| K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System | NQQ | 2016-02-16 | 76 |
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory | NQQ | 2015-02-06 | 44 |
| K120800 | NVISION VLE IMAGING SYSTEM | NQQ | 2013-04-25 | 405 |
| K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER | NQQ | 2012-07-25 | 97 |
| K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER | NQQ | 2011-12-16 | 84 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-04-11.
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 Ninepoint Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02031900: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System (Completed, started 2013-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ninepoint Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Ninepoint Medical, Inc.” (first 2011, latest 2019), across 1 product code 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 Ninepoint Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ninepoint Medical, Inc. is 80 days. Since 2017: 56 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ninepoint Medical, Inc.?
The most frequent FDA product codes under this applicant name are NQQ (System, Imaging, Optical Coherence Tomography (Oct), 8).
Next steps
- See all 8 Ninepoint Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQQ, Ninepoint Medical, 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.