Neurologica Corporation: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Neurologica Corporation” (first 2005, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 158 days. Since 2017 the median was 162 days, against 114 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 | 1 | 92 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 116 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 161 |
| 2023 | 0 | — |
| 2024 | 1 | 199 |
| 2025 | 1 | 164 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neurologica Corporation took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 7 | 7 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
Review panels
- Radiology (8)
Most recent Neurologica Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250928 | OmniTom Elite with PCD | JAK | 2025-09-08 | 164 |
| K233767 | OmniTom Elite | JAK | 2024-06-10 | 199 |
| K213649 | BodyTom 64 | JAK | 2022-04-29 | 161 |
| K171183 | OmniTom | JAK | 2017-08-18 | 116 |
| K142697 | NExCT 7 | JAK | 2014-12-23 | 92 |
| K102677 | BODYTOM NL 4000 | JAK | 2011-03-24 | 190 |
| K090811 | INSPIRA HD, MODEL: NL1000 | KPS | 2009-08-27 | 155 |
| K051765 | CERETOM, MODEL NL3000 | JAK | 2005-07-14 | 14 |
Recalls
13 product recalls in 12 recall events; 5 initiated in the last five years. Most recent: 2025-10-07.
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.
- Neurologica Corporation, A Subsidiary of Samsung Electronics (4 510(k)s)
- Neurologica Corporation, A Subsidiary of Samsung (2 510(k)s)
- NeuroLogica Corp., a Samsung Company (1 510(k)s)
- Neurologica Corporation, A Subsidiary OF (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurologica Corporation?
FDA lists 8 510(k) clearances under the applicant name “Neurologica Corporation” (first 2005, latest 2025), across 2 product codes 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 Neurologica Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurologica Corporation is 158 days. Since 2017: 162 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neurologica Corporation?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 7); KPS (System, Tomography, Computed, Emission, 1).
Next steps
- See all 8 Neurologica Corporation clearances with predicates and recalls
- Run predicate analysis for product code JAK, Neurologica 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 (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.