# Merit Medical Ireland, Ltd.

- Location (FDA's records): Galway, IE
- FDA decisions: 6 (2012–2026): 6 510(k) clearances
- Names in FDA's records: Merit Medical Ireland, Ltd. (5); Merit Medical Ireland , Ltd. (1)
- Product codes: DQX (5), MAV (1)
- 510(k) review time since 2016: median 135 days, against 145 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Merit Medical Systems, Inc.: 5 (https://510kreport.com/company/merit-medical-systems)
- Lake Region Medical: 1 (https://510kreport.com/company/lake-region-medical)

## Firms that cite its devices most
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)

## Its most-cited devices
- 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) (2025), cited by 1
- K122321: Basixconpak Analog Inflation Syringe (2012), cited by 1

## Recent decisions
- K261640: Merit MAK Nitinol/Gold-Tungsten Guide Wire (Jul 13, 2026)
- K254137: InQwire Amplatz Guide Wire (May 22, 2026)
- K253847: Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (Jan 31, 2026)
- 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) (Jan 21, 2026)
- 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) (Aug 29, 2025)
- K122321: Basixconpak Analog Inflation Syringe (Dec 19, 2012)

Source page: https://510kreport.com/company/merit-medical-ireland