Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Merit Medical System, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | 2025-09-10 | 30 | 0 |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024-02-12 | 266 | 0 |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 | 23 | 0 |
| K212817 | Merit Siege Vascular Plug | Merit Medical System, Inc. | 2021-12-15 | 103 | 0 |
| K193571 | Go2Wire Guide Wire | Merit Medical System, Inc. | 2020-04-08 | 107 | 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