Merit Medical System, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Merit Medical System, Inc.” (first 2020, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 103 days. Since 2017 the median was 103 days, against 126 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 |
|---|---|---|
| 2020 | 1 | 107 |
| 2021 | 1 | 103 |
| 2022 | 0 | — |
| 2023 | 1 | 23 |
| 2024 | 1 | 266 |
| 2025 | 1 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Merit Medical System, Inc. took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
| NEU | Marker, Radiographic, Implantable | 1 | 1 |
| QJH | Reverse Central Venous Recanalization System | 1 | 1 |
Review panels
Most recent Merit Medical System, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252527 | Surfacer Inside-Out Access Catheter System | QJH | 2025-09-10 | 30 |
| K231468 | SCOUT MD Surgical Guidance System | NEU | 2024-02-12 | 266 |
| K230636 | Maestro Microcatheter | KRA | 2023-03-30 | 23 |
| K212817 | Merit Siege Vascular Plug | KRD | 2021-12-15 | 103 |
| K193571 | Go2Wire Guide Wire | DQX | 2020-04-08 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Merit Medical System, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Merit Medical System, Inc. (a text match, not an official crosswalk):
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.
- Merit Medical Systems, Inc. (181 510(k)s)
- Merit Medical Ireland, Ltd. (6 510(k)s)
- Merit Cables Incorporated (1 510(k)s)
- Merit Cro, Inc. (1 510(k)s)
- Merit Medical Pte. , Ltd. (1 510(k)s)
- Merit Medical Singapore Pte. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merit Medical System, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Merit Medical System, Inc.” (first 2020, latest 2025), across 5 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 Merit Medical System, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merit Medical System, Inc. is 103 days. Since 2017: 103 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Merit Medical System, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 1); KRA (Catheter, Continuous Flush, 1); KRD (Device, Vascular, For Promoting Embolization, 1).
Next steps
- See all 5 Merit Medical System, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Merit Medical System, 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.