Neurocom International, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Neurocom International, Inc.” (first 1985, latest 1995), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| KHX | Platform, Force-Measuring | 2 | 2 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| LXV | Apparatus, Vestibular Analysis | 1 | 1 |
Review panels
- Ear, Nose and Throat (2)
- Physical Medicine (2)
- Neurology (1)
Most recent Neurocom International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946229 | BALANCE MANAGER | KHX | 1995-08-04 | 225 |
| K901732 | EMG ACCESSORY FOR POSTUROGRAPHY | IKN | 1991-09-10 | 511 |
| K871652 | NEUROCOM PRESSURE TEST SYSTEM | ETY | 1987-07-16 | 79 |
| K863443 | DUAL FORCEPLATE | KHX | 1986-09-17 | 12 |
| K851744 | EQUITEST | LXV | 1985-08-05 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Neurocom International, 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 Neurocom International, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Neurocom International, Inc.” (first 1985, latest 1995), across 4 product codes in 3 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 Neurocom International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurocom International, Inc. is 98 days.
Which FDA product codes appear under Neurocom International, Inc.?
The most frequent FDA product codes under this applicant name are KHX (Platform, Force-Measuring, 2); ETY (Tester, Auditory Impedance, 1); IKN (Electromyograph, Diagnostic, 1).
Next steps
- See all 5 Neurocom International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KHX, Neurocom International, 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.