Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ninepoint Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
405 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | 2019-07-19 | 84 | 0 |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, Nvision | Ninepoint Medical, Inc. | 2018-11-02 | 42 | 0 |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018-10-16 | 56 | 0 |
| K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm b | Ninepoint Medical, Inc. | 2016-02-16 | 76 | 0 |
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, Nvision | Ninepoint Medical, Inc. | 2015-02-06 | 44 | 0 |
| K120800 | NVISION VLE IMAGING SYSTEM | Ninepoint Medical, Inc. | 2013-04-25 | 405 | 0 |
| K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER | Ninepoint Medical, Inc. | 2012-07-25 | 97 | 0 |
| K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER | Ninepoint Medical, Inc. | 2011-12-16 | 84 | 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