Neurovision Medical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Neurovision Medical Products, Inc.” (first 2010, latest 2013), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 109 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 | 233 |
| 2013 | 2 | 203 |
| 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | 5 | 5 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| PDQ | Neurosurgical Nerve Locator | 1 | 1 |
Review panels
Most recent Neurovision Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | BZQ | 2013-12-26 | 297 |
| K130806 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | PDQ | 2013-07-12 | 109 |
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | FAP | 2012-12-13 | 357 |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | ETN | 2012-10-19 | 109 |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | ETN | 2011-11-03 | 209 |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | GWF | 2011-09-30 | 255 |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | ETN | 2011-06-28 | 106 |
| K110138 | PAIRED HYDROGEL ELECTRODE | ETN | 2011-04-08 | 80 |
| K102862 | NEUROVISION SE (NERVEANA) | ETN | 2010-12-21 | 82 |
Recalls
12 product recalls in 4 recall events; 2 initiated in the last five years. Most recent: 2025-05-19.
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 Neurovision Medical Products, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06499142: STP.168 Clinical Study Protocol Parakeet (Active not recruiting, started 2023-12-18)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Neurovision, Inc. (1 510(k)s)
- Neurovision Imaging, LLC (1 510(k)s)
- Neurovision Medical Product, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurovision Medical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Neurovision Medical Products, Inc.” (first 2010, latest 2013), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neurovision Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurovision Medical Products, Inc. is 109 days.
Which FDA product codes appear under Neurovision Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are ETN (Stimulator, Nerve, 5); BZQ (Monitor, Breathing Frequency, 1); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 1).
Next steps
- See all 9 Neurovision Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETN, Neurovision Medical Products, 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.