Meridian Co., Ltd.: FDA clearances and approvals
Meridian Co., Ltd. has 7 FDA 510(k) clearances (first 2000, latest 2011), across 4 product codes in 3 review panels. Median 510(k) review time: 189 days. It files with the SEC as Meridian Corp (MRBK).
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 |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | 3 | 3 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 1 | 1 |
Review panels
- Neurology (3)
- Physical Medicine (3)
- Cardiovascular (1)
Most recent Meridian Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102375 | LUCIA | ILY | 2011-02-25 | 189 |
| K081962 | LAPEX BCS | ILY | 2008-12-29 | 173 |
| K034009 | LAPEX 2000 | NHN | 2005-01-21 | 394 |
| K023238 | MCPULSE | JOM | 2003-02-19 | 145 |
| K020360 | ABR-2000 | GZO | 2002-08-29 | 206 |
| K010897 | MERIDIAN-PORTABLE | GZO | 2001-06-19 | 85 |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | GZO | 2000-11-03 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Meridian Co., 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.
SEC filings
Meridian Corp (MRBK): EDGAR filings, CIK 1750735. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Meridian Co., Ltd. have?
Meridian Co., Ltd. has 7 FDA 510(k) clearances (first 2000, latest 2011), across 4 product codes in 3 review panels.
How long does FDA take to clear Meridian Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Meridian Co., Ltd.'s cleared 510(k)s is 189 days.
What devices does Meridian Co., Ltd. make?
Its most frequent FDA product codes are GZO (Device, Galvanic Skin Response Measurement, 3); ILY (Lamp, Infrared, Therapeutic Heating, 2); JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, 1).
Has Meridian Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Meridian Co., Ltd. Related entities may recall under other names.
Next steps
- See all 7 Meridian Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZO, Meridian Co., 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.