Nico Corporation: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Nico Corporation” (first 2012, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 58 days, against 113 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 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 64 |
| 2016 | 2 | 120 |
| 2017 | 1 | 27 |
| 2018 | 1 | 23 |
| 2019 | 1 | 88 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 203 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nico Corporation took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 3 | 3 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 1 | 1 |
Review panels
Most recent Nico Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232567 | Myriad SPECTRA Light Source | QFX | 2024-03-14 | 203 |
| K191599 | NICO Myriad NOVUS | GEI | 2019-09-13 | 88 |
| K182340 | NICO Myriad | GEI | 2018-09-20 | 23 |
| K172433 | NICO BrainPath | GZT | 2017-09-07 | 27 |
| K161307 | NICO Myriad | GEI | 2016-12-21 | 225 |
| K162075 | NICO TRIOwand | GEI | 2016-08-11 | 15 |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | GZT | 2015-06-12 | 119 |
| K150993 | NICO TRIOwand | GEI | 2015-04-23 | 8 |
| K120691 | BRAIN PORT | GZT | 2012-06-05 | 90 |
Recalls
7 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2021-04-30.
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.
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.
- Nico Metal Products Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nico Corporation?
FDA lists 9 510(k) clearances under the applicant name “Nico Corporation” (first 2012, latest 2024), across 3 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 Nico Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nico Corporation is 88 days. Since 2017: 58 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nico Corporation?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); GZT (Retractor, Self-Retaining, For Neurosurgery, 3); QFX (Diagnostic Neurosurgical Microscope Filter, 1).
Next steps
- See all 9 Nico Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEI, Nico Corporation'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.