Merit Medical Systems, Inc.: FDA clearances and approvals
Merit Medical Systems, Inc. has 181 FDA 510(k) clearances (first 1988, latest 2026), plus 1 PMA decision, across 50 product codes in 10 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 96 days, against 125 days for all cleared 510(k)s in the same product codes. openFDA lists 300 product recalls by a recalling firm named Merit Medical Systems, Inc. It is the industry lead sponsor of 18 device clinical trials on ClinicalTrials.gov. It files with the SEC as MERIT MEDICAL SYSTEMS INC (MMSI).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 68 |
| 2013 | 10 | 62 |
| 2014 | 13 | 142 |
| 2015 | 8 | 76 |
| 2016 | 7 | 114 |
| 2017 | 13 | 85 |
| 2018 | 8 | 74 |
| 2019 | 4 | 55 |
| 2020 | 6 | 108 |
| 2021 | 6 | 132 |
| 2022 | 4 | 196 |
| 2023 | 6 | 76 |
| 2024 | 3 | 195 |
| 2025 | 6 | 106 |
| 2026 | 4 | 122 |
Review time against the same product codes
Since 2017, Merit Medical Systems, Inc.'s cleared 510(k)s took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 22 | 22 |
| DYB | Introducer, Catheter | 19 | 19 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 10 | 10 |
| FMF | Syringe, Piston | 10 | 10 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 9 | 9 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 9 | 9 |
| DQO | Catheter, Intravascular, Diagnostic | 8 | 8 |
| DXT | Injector And Syringe, Angiographic | 7 | 7 |
| KRA | Catheter, Continuous Flush | 7 | 7 |
| DQY | Catheter, Percutaneous | 6 | 6 |
Plus 40 more product codes.
Review panels
- Cardiovascular (113)
- General Hospital (23)
- Anesthesiology (18)
- Gastroenterology and Urology (14)
- General and Plastic Surgery (7)
- Ear, Nose and Throat (2)
- Obstetrics and Gynecology (2)
- Microbiology (1)
- Neurology (1)
- Orthopedic (1)
Most recent Merit Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | DRE | 2026-07-27 | 97 |
| K262086 | PreludeSYNC Radial Compression Device | DXC | 2026-07-22 | 30 |
| K254073 | StatSeal Disc | FRO | 2026-05-13 | 146 |
| K251802 | STAR RF Ablation System | GXI | 2026-02-13 | 246 |
| K252892 | SCOUT MD Surgical Guidance System | NEU | 2025-12-19 | 99 |
| K250853 | Merit Syringe | FMF | 2025-11-04 | 228 |
| K251265 | Resilience Fully Covered Esophageal Stent System | ESW | 2025-07-23 | 90 |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | DYB | 2025-04-25 | 30 |
| K242873 | Ventrax Delivery System | DQY | 2025-01-15 | 114 |
| K242229 | Micro Ace Gold Advanced Micro Access System | DRE | 2025-01-15 | 169 |
171 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240023 | PMA | WRAPSODY® Cell-Impermeable Endoprosthesis | 2024-12-19 |
Recalls
300 product recalls in 93 recall events; 92 initiated in the last five years. Most recent: 2026-08-10.
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.
Device clinical trials
Merit Medical Systems, Inc. is the industry lead sponsor of 18 device studies on ClinicalTrials.gov (8 active or recruiting). Most recent:
- NCT06807099: WRAP North America (Recruiting, started 2025-07-31)
- NCT06422871: PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis (Recruiting, started 2025-07-28)
- NCT06587282: PREEMIE: Study for Treatment of PDA in Premature Infants (Active not recruiting, started 2025-03-06)
- NCT06153667: Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE) (Recruiting, started 2024-08-22)
- NCT05818150: GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION) (Active not recruiting, started 2024-01-16)
SEC filings
MERIT MEDICAL SYSTEMS INC (MMSI): EDGAR filings, CIK 856982. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Merit Medical Systems, Inc.'s product codes (a text match, not an official crosswalk):
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- G0379 — Direct admission of patient for hospital observation care (via DWM)
Frequently asked questions
How many FDA 510(k) clearances does Merit Medical Systems, Inc. have?
Merit Medical Systems, Inc. has 181 FDA 510(k) clearances (first 1988, latest 2026), plus 1 PMA decision, across 50 product codes in 10 review panels.
How long does FDA take to clear Merit Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Merit Medical Systems, Inc.'s cleared 510(k)s is 90 days. Since 2017: 96 days, versus 125 days for all cleared 510(k)s in the same product codes.
What devices does Merit Medical Systems, Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 22); DYB (Introducer, Catheter, 19); DRE (Dilator, Vessel, For Percutaneous Catheterization, 10).
Has Merit Medical Systems, Inc. had device recalls?
openFDA lists 300 product recalls in 93 recall events by a recalling firm whose name matches Merit Medical Systems, Inc; the most recent began 2026-08-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 181 Merit Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Merit Medical Systems, Inc.'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.