Meditec Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Meditec Co., Ltd.” (first 1983, latest 2004), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Meditec Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041789 | NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T | DXN | 2004-07-15 | 13 |
| K002655 | DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 | DXN | 2000-09-06 | 12 |
| K992328 | FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 | DXN | 1999-07-21 | 9 |
| K990380 | (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 | DXN | 1999-02-22 | 14 |
| K854833 | MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI | GEX | 1986-04-04 | 126 |
| K852234 | MDS 83 OPHTHALMIC DYE LASER SYSTEM | HQF | 1985-08-01 | 71 |
| K832983 | DERMOLAS | GEX | 1984-04-23 | 234 |
| K837030 | MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM | — | 1983-01-24 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Meditec Co., Ltd..
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.
- Meditec of America (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meditec Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Meditec Co., Ltd.” (first 1983, latest 2004), 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 Meditec Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meditec Co., Ltd. is 24 days.
Which FDA product codes appear under Meditec Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); GEX (Powered Laser Surgical Instrument, 2); HQF (Laser, Ophthalmic, 1).
Next steps
- See all 8 Meditec Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Meditec Co., Ltd.'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.