Company · US
Merit Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2026. Name variants (Inc, Corp, punctuation) are merged.
181510(k) clearances (6 in 12 months)
301recalls (19 in 12 months)
208recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 54 |
| DQO | Catheter, Intravascular, Diagnostic | 41 |
| KRA | Catheter, Continuous Flush | 34 |
| DQX | Wire, Guide, Catheter | 31 |
| FMF | Syringe, Piston | 30 |
| DXT | Injector And Syringe, Angiographic | 25 |
| OEQ | Angiography/Angioplasty Kit | 20 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 16 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 16 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | 14 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 13 |
| MAV | Syringe, Balloon Inflation | 13 |
| FPA | Set, Administration, Intravascular | 12 |
| OEZ | Cardiovascular Procedure Kit | 10 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 9 |
| DQY | Catheter, Percutaneous | 8 |
| MSD | Catheter, Hemodialysis, Implanted | 7 |
| OJV | Single Use Instrument Tray | 7 |
| PTM | Syringe, Balloon Inflation, Exempt | 6 |
| QEY | Mechanical Thrombolysis Catheter | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 2026 | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set Merit Medical Systems, Inc. | DRE |
| Jul 22, 2026 | K262086 | PreludeSYNC Radial Compression Device Merit Medical Systems, Inc. | DXC |
| May 13, 2026 | K254073 | StatSeal Disc Merit Medical Systems, Inc. | FRO |
| Feb 13, 2026 | K251802 | STAR RF Ablation System Merit Medical Systems, Inc. | GXI |
| Dec 19, 2025 | K252892 | SCOUT MD Surgical Guidance System Merit Medical Systems, Inc. | NEU |
| Nov 4, 2025 | K250853 | Merit Syringe Merit Medical Systems, Inc. | FMF |
| Jul 23, 2025 | K251265 | Resilience Fully Covered Esophageal Stent System Merit Medical Systems, Inc. | ESW |
| Apr 25, 2025 | K250909 | Prelude Wave Hydrophilic Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Jan 15, 2025 | K242873 | Ventrax Delivery System Merit Medical Systems, Inc. | DQY |
| Jan 15, 2025 | K242229 | Micro Ace Gold Advanced Micro Access System Merit Medical Systems, Inc. | DRE |
| Dec 10, 2024 | K241521 | Prelude Small O.D. Introducer Guide Wire Merit Medical Systems, Inc. | DQX |
| May 22, 2024 | K233268 | Impress Angiographic Catheter Merit Medical Systems, Inc. | DQO |
| May 2, 2024 | K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) Merit Medical Systems, Inc. | KRD |
| Dec 21, 2023 | K233813 | Bearing nsPVA Express Merit Medical Systems, Inc. | NAJ |
| Oct 28, 2023 | K230418 | Mighty Wire Guide Wire Merit Medical Systems, Inc. | DQX |
| Sep 27, 2023 | K232609 | Micro Ace Advanced Micro Access System Merit Medical Systems, Inc. | DRE |
| Aug 30, 2023 | K231246 | Ventrax Delivery System (VTR851) Merit Medical Systems, Inc. | DQY |
| Mar 3, 2023 | K212696 | Aspira Pleural Drainage System Merit Medical Systems, Inc. | DWM |
| Jan 19, 2023 | K223872 | Low Profile Companion Sheath Merit Medical Systems, Inc. | DYB |
| Aug 15, 2022 | K213845 | HeRO Graft Merit Medical Systems, Inc. | DSY |
| Apr 8, 2022 | K212882 | SCOUT BX Delivery System Merit Medical Systems, Inc. | NEU |
| Mar 8, 2022 | K213434 | Elation Pulmonary Balloon Dilation Catheter Merit Medical Systems, Inc. | KTI |
| Jan 7, 2022 | K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer Merit Medical Systems | DYB |
| Dec 14, 2021 | K212675 | Aspira Peritoneal Drainage System Merit Medical Systems, Inc. | PNG |
| Nov 3, 2021 | K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter Merit Medical Systems, Inc. | QEZ |
| Oct 4, 2021 | K211405 | Prelude Guide Sheath Merit Medical Systems, Inc. | DYB |
| Jul 16, 2021 | K211525 | SwiftNINJA Steerable Microcatheter Merit Medical Systems, Inc. | KRA |
| May 25, 2021 | K203724 | HeRO Graft, HeRO Adapter Merit Medical Systems, Inc. | DSY |
| Mar 3, 2021 | K201674 | Cultura Collection and Transport System Merit Medical Systems, Inc. | JSM |
| Dec 14, 2020 | K202610 | Ventrax Delivery System Merit Medical Systems, Inc. | DQY |
| Oct 14, 2020 | K201595 | Merit Hydrophilic Guide Wire Merit Medical Systems, Inc., IE | DQX |
| Aug 28, 2020 | K201166 | Temno Elite Biopsy System Merit Medical Systems, Inc. | KNW |
| Aug 7, 2020 | K193082 | Fountain ValveTip Infusion Catheter Merit Medical Systems, Inc. | KRA |
| Aug 6, 2020 | K201907 | ClariVein IC Merit Medical Systems, Inc. | KRA |
| Jan 17, 2020 | K193507 | Merit ONE Snare System Merit Medical Systems, Inc., IE | MMX |
| Nov 26, 2019 | K192907 | Advocate PTA Catheter Merit Medical Systems, Inc., IE | LIT |
| Oct 9, 2019 | K191596 | Arcadia Balloon Catheter Merit Medical Systems, Inc. | HRX |
| Jul 16, 2019 | K191608 | Impress Angiographic Catheter Merit Medical Systems, Inc. | DQO |
| Apr 10, 2019 | K190175 | S-MAK XL Merit Medical Systems, Inc. | DRE |
| Nov 6, 2018 | K182279 | Merit Syringe Merit Medical Systems, Inc. | FMF |
| Nov 6, 2018 | K182216 | Merit Syringe Merit Medical Systems, Inc. | FMF |
| Sep 21, 2018 | K181200 | AEROmini Tracheobronchial Stent System Merit Medical Systems, Inc. | JCT |
| Apr 17, 2018 | K180723 | PreludeSYNC DISTAL Radial Compression System Merit Medical Systems, Inc. | DXC |
| Mar 30, 2018 | K173548 | Merit Pursue Microcatheter Merit Medical Systems, Inc. | DQY |
| Mar 12, 2018 | K180450 | Corvocet Biopsy System Merit Medical Systems, Inc. | KNW |
| Feb 15, 2018 | K173750 | Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Jan 31, 2018 | K173601 | Merit Syringe Merit Medical Systems, Inc. | FMF |
| Dec 13, 2017 | K173621 | Advocate PTA Catheter Merit Medical Systems, Inc., IE | LIT |
| Nov 30, 2017 | K172637 | HeRO Graft Merit Medical Systems, Inc. | DSY |
| Sep 11, 2017 | K172117 | Prelude Pursuit Splittable Sheath Introducer Merit Medical Systems, Inc. | DYB |
Newest 50 of 181.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Merit Medical Systems, Inc. Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01
Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO Open, Classified |
NEU | K252892 |
| Sep 25, 2026 | Merit Medical Systems, Inc. Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:
S420GH/EUA, S620GH/EUA;
Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;
Embosphere 900-1200 micrometer 2 mL Open, Classified |
KRD | K181300 |
| Jun 18, 2026 | Merit Medical Systems, Inc. Splashwire Hydrophilic Guide Wire:
REF: MSWSTDA35150
UDI-DI codes:
00884450529645
00884450529669
00884450529690
REF: MSWSTDA35180
UDI-DI codes:
00884450529645
00884450529669
REF: MSWSTDA35260EX
UDI- Open, Classified |
DQX | K201595 |
| Apr 29, 2026 | Merit Medical Systems, Inc. Philips Bridge Prep Kit
REF: K12-09098C
Sterile EO, Rx ONLY Open, Classified |
OEQ | None listed |
| Apr 29, 2026 | Merit Medical Systems, Inc. Philips Bridge Prep Kit
REF: K12-09098C
Sterile EO, Rx ONLY Open, Classified |
OEQ | None listed |
| Apr 29, 2026 | Merit Medical Systems, Inc. Philips Bridge Prep Kit
REF: K12-09098B
Sterile EO, Rx ONLY Open, Classified |
OEQ | None listed |
| Mar 26, 2026 | Merit Medical Systems, Inc. BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061 Open, Classified |
MSD | K131260 |
| Mar 26, 2026 | Merit Medical Systems, Inc. DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H78 Open, Classified |
MSD | K101843 |
| Mar 26, 2026 | Merit Medical Systems, Inc. 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B Open, Classified |
DYB | K043438 |
| Mar 26, 2026 | Merit Medical Systems, Inc. ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C Open, Classified |
MSD | K090148 |
| Mar 26, 2026 | Merit Medical Systems, Inc. CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A Open, Classified |
MSD | K151967 |
| Jan 16, 2026 | Merit Medical Systems, Inc. Allwell Angioplasty Pack
REF: IS-30-B1/B Open, Classified |
OEQ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical , Custom Procedure Kit
Reference Numbers: K12T-04270A K12T-07956 K12T-10922B Open, Classified |
OEQ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical , Custom Manifold Kit
REF: K09-13203A Open, Classified |
OEZ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical , Custom Inflation Kit
REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T- Open, Classified |
PPD | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical , Custom Waste Management Kit Vascular Tray
REF: K10T-05261 Open, Classified |
PPD | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Allwell Inflation Device, for angiographic use
REF: IS-30-A Open, Classified |
OEQ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL
Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330 Open, Classified |
PTM | None listed |
| Nov 17, 2025 | Merit Medical Systems, Inc. PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP80 Open, Classified |
DTL | None listed |
| Sep 11, 2025 | Merit Medical Systems, Inc. 10Fore Hemostasis Valve
Catalog Number / UDI-DI code:
MAPTEN4 / 00884450821305
MAPTEN42 / 00884450832509
MAPTEN452 / 00884450821329
The 10Fore Hemostasis Valve is intended to maintain hemostasis duri Open, Classified |
DTL | None listed |
| Aug 12, 2025 | Merit Medical Systems, Inc. Custom Waste Management Kit:
REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP Open, Classified |
PPD | None listed |
| Aug 12, 2025 | Merit Medical Systems, Inc. Custom Manifold Kit:
REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B Open, Classified |
OEZ | None listed |
| Aug 12, 2025 | Merit Medical Systems, Inc. Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 Open, Classified |
OJA | None listed |
| Aug 12, 2025 | Merit Medical Systems, Inc. High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C Open, Classified |
FPK | K883718 |
| Apr 21, 2025 | Merit Medical Systems, Inc. Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly Open, Classified |
ODE | K240879 |
| Apr 21, 2025 | Merit Medical Systems, Inc. Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly Open, Classified |
ODE | K240879 |
| Mar 24, 2025 | Merit Medical Systems, Inc. Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Open, Classified |
DYB | K173750 |
| Oct 11, 2024 | Merit Medical Systems, Inc. StabiliT TOUCH Syringe, REF: IN8VCF/B Open, Classified |
OAR | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. basixSKY Inflation Device, REF: SKY1802 Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-0 Open, Classified |
OEQ | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. BlueFIRE Inflation Device, REF: IN10140 Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. IntelliSystem Inflation Device, REF: IN1525/D Open, Classified |
DXT | K884913 |
| Oct 11, 2024 | Merit Medical Systems, Inc. DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Open, Classified |
DXT | K160107 |
| Oct 11, 2024 | Merit Medical Systems, Inc. basixTOUCH Inflation Device, REF: IN8140/A Open, Classified |
PTM | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C Open, Classified |
DXT | K083523 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Melrose Wakefield Hospital REF K05T-2159
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syring Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syri Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch s Open, Classified |
DXT | K011811 |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar REF IN2130
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters Open, Classified |
DXT | K011811 |
| Sep 20, 2024 | Merit Medical Systems, Inc. Custom Procedure Kit, REF: K12T-11077 Open, Classified |
OEQ | None listed |
| Sep 20, 2024 | Merit Medical Systems, Inc. Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) Open, Classified |
DRE | K070159 |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Customer Procedure Kit (Angiography/Angioplasty kit), REF:
K09T-01138
K09T-04484A
K09 Open, Classified |
OEZ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:
FCL-083-02/A
WOR-C Open, Classified |
DYB | K120158 |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF:
SPPT-100/D
SPPT-5F-1 Open, Classified |
PYC | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Prelude SNAP-H (Introducer Catheter kit), REF:
PLSH-1006/A
PLSH-1007/A
PLSH-1008/A
PL Open, Classified |
DYB | K152381 |
Newest 50 of 301.