Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Merit Medical Ireland , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
261 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | 2026-07-13 | 56 | 0 |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | 2026-05-22 | 151 | 0 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | 2026-01-31 | 60 | 0 |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super | Merit Medical Ireland, Ltd. | 2026-01-21 | 261 | 0 |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashw | Merit Medical Ireland, Ltd. | 2025-08-29 | 135 | 0 |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | Merit Medical Ireland, Ltd. | 2012-12-19 | 140 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda