Meridian AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Meridian AG” (first 2002, latest 2024), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 122 days. Since 2017 the median was 167 days, against 90 days for all cleared 510(k)s in the same product codes. 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 | 1 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 435 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 155 |
| 2024 | 1 | 167 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Meridian AG took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQF | Laser, Ophthalmic | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | 1 | 1 |
Review panels
Most recent Meridian AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | HQF | 2024-01-25 | 167 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | HQF | 2023-09-12 | 155 |
| K160677 | MICRORUPTOR 6 | GEX | 2017-05-19 | 435 |
| K113390 | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) | GEX | 2012-02-14 | 90 |
| K072823 | MERILAS 532A | HQF | 2007-12-14 | 73 |
| K023045 | MICRORUPTER V | LXS | 2002-09-26 | 14 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840012 | PMA | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM | 1986-01-31 |
Recalls
openFDA lists no recalls under a recalling firm named Meridian AG.
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 Medical Systems, LLC (8 510(k)s)
- Meridian Co., Ltd. (7 510(k)s)
- Meridian Medical Technologies, Inc. (6 510(k)s)
- Meridian Bioscience Israel , Ltd. (3 510(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 AG?
FDA lists 6 510(k) clearances under the applicant name “Meridian AG” (first 2002, latest 2024), plus 1 PMA decision, across 4 product codes in 2 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 Meridian AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meridian AG is 122 days. Since 2017: 167 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Meridian AG?
The most frequent FDA product codes under this applicant name are HQF (Laser, Ophthalmic, 3); GEX (Powered Laser Surgical Instrument, 2); LOI (Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary, 1).
Next steps
- See all 6 Meridian AG clearances with predicates and recalls
- Run predicate analysis for product code HQF, Meridian AG'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.