Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Merit Medical Systems, Inc. — Predicate Candidate Screening
180 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
226 days90th percentile
180clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026-07-27 | 97 | 0 |
| K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026-07-22 | 30 | 0 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 | 146 | 0 |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | 2026-02-13 | 246 | 0 |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | 2025-12-19 | 99 | 0 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 | 228 | 0 |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025-07-23 | 90 | 0 |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2025-04-25 | 30 | 0 |
| K242873 | Ventrax™ Delivery System | Merit Medical Systems, Inc. | 2025-01-15 | 114 | 0 |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | 2025-01-15 | 169 | 0 |
| K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | 2024-12-10 | 195 | 0 |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2024-05-22 | 236 | 0 |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP | Merit Medical Systems, Inc. | 2024-05-02 | 92 | 0 |
| K233813 | Bearing nsPVA Express™ | Merit Medical Systems, Inc. | 2023-12-21 | 21 | 0 |
| K230418 | Mighty Wire Guide Wire | Merit Medical Systems, Inc. | 2023-10-28 | 254 | 0 |
| K232609 | Micro Ace™ Advanced Micro Access System | Merit Medical Systems, Inc. | 2023-09-27 | 30 | 0 |
| K231246 | Ventrax™ Delivery System (VTR851) | Merit Medical Systems, Inc. | 2023-08-30 | 121 | 0 |
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | 2023-03-03 | 555 | 0 |
| K223872 | Low Profile Companion Sheath | Merit Medical Systems, Inc. | 2023-01-19 | 27 | 0 |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | 2022-08-15 | 249 | 0 |
| K212882 | SCOUT BX Delivery System | Merit Medical Systems, Inc. | 2022-04-08 | 210 | 0 |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | 2022-03-08 | 137 | 0 |
| K212675 | Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. | 2021-12-14 | 112 | 13 |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2021-11-03 | 112 | 0 |
| K211405 | Prelude Guide Sheath | Merit Medical Systems, Inc. | 2021-10-04 | 151 | 3 |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | 2021-07-16 | 60 | 0 |
| K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | 2021-05-25 | 155 | 0 |
| K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021-03-03 | 257 | 0 |
| K202610 | Ventrax Delivery System | Merit Medical Systems, Inc. | 2020-12-14 | 96 | 0 |
| K201595 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2020-10-14 | 124 | 1 |
| K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | 2020-08-28 | 119 | 0 |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | 2020-08-07 | 276 | 0 |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020-08-06 | 28 | 0 |
| K193507 | Merit ONE Snare System | Merit Medical Systems, Inc. | 2020-01-17 | 30 | 0 |
| K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2019-11-26 | 42 | 0 |
| K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | 2019-10-09 | 114 | 0 |
| K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019-07-16 | 29 | 0 |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | 2019-04-10 | 68 | 0 |
| K182216 | Merit Syringe | Merit Medical Systems, Inc. | 2018-11-06 | 83 | 0 |
| K182279 | Merit Syringe | Merit Medical Systems, Inc. | 2018-11-06 | 76 | 0 |
| K181200 | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | 2018-09-21 | 137 | 0 |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. | 2018-04-17 | 29 | 0 |
| K173548 | Merit Pursue Microcatheter | Merit Medical Systems, Inc. | 2018-03-30 | 134 | 1 |
| K180450 | Corvocet Biopsy System | Merit Medical Systems, Inc. | 2018-03-12 | 20 | 2 |
| K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2018-02-15 | 69 | 1 |
| K173601 | Merit Syringe | Merit Medical Systems, Inc. | 2018-01-31 | 71 | 0 |
| K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017-12-13 | 21 | 0 |
| K172637 | HeRO Graft | Merit Medical Systems, Inc. | 2017-11-30 | 90 | 0 |
| K172117 | Prelude Pursuit Splittable Sheath Introducer | Merit Medical Systems, Inc. | 2017-09-11 | 60 | 1 |
| K171362 | Merit Syringe | Merit Medical Systems, Inc. | 2017-08-07 | 90 | 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