Meridian Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Meridian Medical Technologies, Inc.” (first 1997, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 149 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (3)
Most recent Meridian Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030104 | PRIME ECG SYSTEM | DPS | 2003-06-11 | 149 |
| K012414 | PRIME ECG SYSTEM | DPS | 2002-03-06 | 219 |
| K965101 | CARDIOBEEPER CB-12L | DXH | 1997-03-17 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Meridian Medical Technologies, 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.
- Meridian Diagnostics, Inc. (92 510(k)s)
- Meridian Bioscience, Inc. (37 510(k)s)
- Meridian Co., Ltd. (7 510(k)s)
- Meridian AG (6 510(k)s)
- Meridian Medical Systems, LLC (6 510(k)s)
- Meridian Bioscience Israel , Ltd. (3 510(k)s)
- Meridian Medical Technologies , Ltd. (3 510(k)s)
- Meridian Medical Systems, Inc. (2 510(k)s)
- Meridian Dynamics Biomedical, Inc. (1 510(k)s)
- Meridian Medical (1 510(k)s)
- Meridian Technique, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meridian Medical Technologies, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Meridian Medical Technologies, Inc.” (first 1997, latest 2003), across 2 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 Meridian Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meridian Medical Technologies, Inc. is 149 days.
Which FDA product codes appear under Meridian Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 3 Meridian Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Meridian Medical Technologies, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.