Neurovirtual USA, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Neurovirtual USA, Inc.” (first 2006, latest 2020), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 229 days. Since 2017 the median was 266 days, against 166 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 635 |
| 2016 | 0 | — |
| 2017 | 1 | 116 |
| 2018 | 0 | — |
| 2019 | 1 | 782 |
| 2020 | 3 | 266 |
| 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 Neurovirtual USA, Inc. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 3 | 3 |
| MNR | Ventilatory Effort Recorder | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
Review panels
- Neurology (5)
- Anesthesiology (3)
Most recent Neurovirtual USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201495 | Maxxi Flow Sensor | MNR | 2020-12-14 | 192 |
| K191492 | Maxxi Position Sensor | GWQ | 2020-04-24 | 324 |
| K191095 | Maxxi Snore Sensor | MNR | 2020-01-16 | 266 |
| K171304 | Maxxi Rip Sensor | MNR | 2019-06-24 | 782 |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | GXY | 2017-04-11 | 116 |
| K131335 | BWMINI EEG, BWMINIHST, BWMINI PSG | GWQ | 2015-02-03 | 635 |
| K112107 | BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS | GWQ | 2011-10-28 | 98 |
| K062533 | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 | OLT | 2006-12-22 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Neurovirtual USA, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurovirtual USA, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Neurovirtual USA, Inc.” (first 2006, latest 2020), across 4 product codes in 2 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 Neurovirtual USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurovirtual USA, Inc. is 229 days. Since 2017: 266 days, versus 166 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neurovirtual USA, Inc.?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 3); MNR (Ventilatory Effort Recorder, 3); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 8 Neurovirtual USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Neurovirtual USA, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.