Clinical Neuro Systems, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Clinical Neuro Systems, LLC” (first 1992, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 3 | 3 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 | 1 |
Review panels
- Neurology (5)
Most recent Clinical Neuro Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | HBG | 1996-06-05 | 77 |
| K930229 | CLINICAL NEURO SYSTEMS CRANIAL DRILL | HBE | 1993-03-16 | 56 |
| K922941 | CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA | JXG | 1992-08-26 | 69 |
| K922936 | CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE | JXG | 1992-08-26 | 69 |
| K920156 | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY | JXG | 1992-03-16 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Clinical Neuro Systems, LLC.
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.
- Clinical Data, Inc. (37 510(k)s)
- Clinical Sciences, Inc. (30 510(k)s)
- Clinical Assays, Inc. (27 510(k)s)
- Clinical Controls, Inc. (18 510(k)s)
- Clinical Innovations, LLC (18 510(k)s)
- Clinical Resources, Inc. (14 510(k)s)
- Clinical Technology Corp. (12 510(k)s)
- Clinical Connections, Inc. (10 510(k)s)
- Clinical Diagnostics, Inc. (8 510(k)s)
- Clinical Convenience Products, Inc. (6 510(k)s)
- Clinical Laserthermia Systems, AB (6 510(k)s)
- Clinical Bioresearch (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Neuro Systems, LLC?
FDA lists 5 510(k) clearances under the applicant name “Clinical Neuro Systems, LLC” (first 1992, latest 1996), across 3 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 Clinical Neuro Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Neuro Systems, LLC is 69 days.
Which FDA product codes appear under Clinical Neuro Systems, LLC?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 3); HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 1); HBG (Drills, Burrs, Trephines & Accessories (Manual), 1).
Next steps
- See all 5 Clinical Neuro Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code JXG, Clinical Neuro Systems, LLC'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.