Medelec Intl. Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Medelec Intl. Corp.” (first 1985, latest 1996), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| GES | Blade, Scalpel | 3 | 3 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| HIS | Condom | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GDX | Scalpel, One-Piece | 1 | 1 |
| GDZ | Handle, Scalpel | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
Plus 1 more product codes.
Review panels
- Neurology (5)
- General and Plastic Surgery (5)
- General Hospital (2)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
Most recent Medelec Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961013 | DISPOSABLE NEEDLE ELECTRODE | IKT | 1996-12-20 | 282 |
| K935017 | TD50 ELECTROMYOGRAPH | JXE | 1994-07-28 | 282 |
| K922548 | MEDELEC 2110 AND 2114 EEG | GWQ | 1992-11-03 | 155 |
| K920127 | ELECTROENCEPHALOGRAPH RECORDING SYSTEM | GWQ | 1992-06-10 | 152 |
| K912775 | SAPPHIRE 4ME EMG/EP SYSTEM | GWF | 1991-11-08 | 137 |
| K865106 | PROPHYLACTIC (CONDOM) MR. JOHNNY | HIS | 1987-05-20 | 140 |
| K863491 | BLOOD SPECIMEN COLLECTION DEVICES | JKA | 1986-10-24 | 46 |
| K854622 | PROPHYLACTIC (CONDOM) | HIS | 1986-04-11 | 144 |
| K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I | BRZ | 1986-01-09 | 56 |
| K854860 | BLADES, SCALPEL CARBON STEET | GES | 1985-12-24 | 19 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medelec Intl. Corp..
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.
- Medelec , Ltd. (8 510(k)s)
- Medelec, Inc. D.B.A. Teca Corp. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medelec Intl. Corp.?
FDA lists 15 510(k) clearances under the applicant name “Medelec Intl. Corp.” (first 1985, latest 1996), across 11 product codes in 5 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 Medelec Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medelec Intl. Corp. is 56 days.
Which FDA product codes appear under Medelec Intl. Corp.?
The most frequent FDA product codes under this applicant name are GES (Blade, Scalpel, 3); GWQ (Full-Montage Standard Electroencephalograph, 2); HIS (Condom, 2).
Next steps
- See all 15 Medelec Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code GES, Medelec Intl. Corp.'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.