Lexicor Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Lexicor Medical Technology, Inc.” (first 1991, latest 1996), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 259 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | 1 | 0 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
Review panels
- Neurology (4)
Most recent Lexicor Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961645 | MRS-2D | HCC | 1996-10-31 | 185 |
| K915820 | NEUROSEARCH-24 OR NRS-24 | OLT | 1995-02-08 | 1136 |
| K904269 | NEUROSEARCH-24 OR NRS-24 | GWQ | 1991-06-04 | 259 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN110019 | De Novo | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | 2013-07-15 |
Recalls
openFDA lists no recalls under a recalling firm named Lexicor Medical Technology, 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.
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.
- Lexicor (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lexicor Medical Technology, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Lexicor Medical Technology, Inc.” (first 1991, latest 1996), plus 1 De Novo decision, across 4 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 Lexicor Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lexicor Medical Technology, Inc. is 259 days.
Which FDA product codes appear under Lexicor Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 1); HCC (Device, Biofeedback, 1); NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, 1).
Next steps
- See all 3 Lexicor Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Lexicor Medical Technology, 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.