Medelec , Ltd.: FDA clearances and approvals
Medelec , Ltd. has 8 FDA 510(k) clearances (first 1992, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time: 138 days.
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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
Review panels
- Neurology (7)
- Anesthesiology (1)
Most recent Medelec , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965065 | TECA. MILLENNIUM | GWF | 1997-06-20 | 184 |
| K964280 | DG NERVUS | GWQ | 1997-01-27 | 91 |
| K954157 | DG PORTABLE SYSTEM | OLT | 1996-01-17 | 134 |
| K953799 | DG EXAMINER PLUS | OLT | 1995-11-08 | 86 |
| K953732 | TECA PREMIERE | GWJ | 1995-10-19 | 80 |
| K934670 | DG 3P SYSTEM | GWQ | 1994-05-25 | 238 |
| K934669 | ARC | BSZ | 1994-04-26 | 209 |
| K923303 | SAPPHIRE PREMIERE | GWF | 1992-11-24 | 141 |
Recalls
openFDA lists no recalls under a recalling firm named Medelec , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medelec , Ltd. have?
Medelec , Ltd. has 8 FDA 510(k) clearances (first 1992, latest 1997), across 5 product codes in 2 review panels.
How long does FDA take to clear Medelec , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Medelec , Ltd.'s cleared 510(k)s is 138 days.
What devices does Medelec , Ltd. make?
Its most frequent FDA product codes are GWF (Stimulator, Electrical, Evoked Response, 2); GWQ (Full-Montage Standard Electroencephalograph, 2); OLT (Non-Normalizing Quantitative Electroencephalograph Software, 2).
Has Medelec , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medelec , Ltd. Related entities may recall under other names.
Next steps
- See all 8 Medelec , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Medelec , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.