Merit Medical Ireland, Ltd.: FDA clearances and approvals
Merit Medical Ireland, Ltd. has 6 FDA 510(k) clearances (first 2012, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 138 days. Since 2017 its median was 135 days, against 134 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 140 |
| 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 | 1 | 135 |
| 2026 | 4 | 106 |
Review time against the same product codes
Since 2017, Merit Medical Ireland, Ltd.'s cleared 510(k)s took a median 135 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 5 | 5 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Merit Medical Ireland, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | DQX | 2026-07-13 | 56 |
| K254137 | InQwire Amplatz Guide Wire | DQX | 2026-05-22 | 151 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | DQX | 2026-01-31 | 60 |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | DQX | 2026-01-21 | 261 |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | DQX | 2025-08-29 | 135 |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | MAV | 2012-12-19 | 140 |
Recalls
openFDA lists no recalls under a recalling firm named Merit Medical Ireland, 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.
Frequently asked questions
How many FDA 510(k) clearances does Merit Medical Ireland, Ltd. have?
Merit Medical Ireland, Ltd. has 6 FDA 510(k) clearances (first 2012, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Merit Medical Ireland, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Merit Medical Ireland, Ltd.'s cleared 510(k)s is 138 days. Since 2017: 135 days, versus 134 days for all cleared 510(k)s in the same product codes.
What devices does Merit Medical Ireland, Ltd. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 5); MAV (Syringe, Balloon Inflation, 1).
Has Merit Medical Ireland, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Merit Medical Ireland, Ltd. Related entities may recall under other names.
Next steps
- See all 6 Merit Medical Ireland, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Merit Medical Ireland, 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.