# Merit Medical Systems, Inc.

- Location (FDA's records): South Jordan, UT
- FDA decisions: 182 (1988–2026): 181 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Merit Medical Systems, Inc. (181); Merit Medical Systems (1)
- Product codes: DQX (22), DYB (19), FMF (10), DRE (10), DTL (9), CAI (9), DQO (8), DXT (7), KRA (7), DQY (6), MAV (6), FGE (5)
- 510(k) review time since 2016: median 92 days, against 92 for FDA's reviews in the same codes and years (25 of 51 faster)
- Predicates its devices cite: 166 (84 its own); citations of its devices by later devices: 178 (84 its own)
- Recalls linked to its devices: 191 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 8 (https://510kreport.com/company/boston-scientific)
- Terumo Medical Corp.: 5 (https://510kreport.com/company/terumo-medical)
- Thomas Medical Products, Inc.: 5 (https://510kreport.com/company/thomas-medical-products)
- Alveolus, Inc.: 4 (https://510kreport.com/company/alveolus)
- Arravasc, Ltd.: 3 (https://510kreport.com/company/arravasc)
- AngioDynamics, Inc.: 3 (https://510kreport.com/company/angiodynamics)
- Welmed, Inc.: 3 (https://510kreport.com/company/welmed)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Cook, Inc.: 5 (https://510kreport.com/company/cook)
- Merit Medical Ireland, Ltd.: 5 (https://510kreport.com/company/merit-medical-ireland)
- Stryker Instruments: 3 (https://510kreport.com/company/stryker-instruments)
- Invatec Innovative Technologies, S.R.L.: 3 (https://510kreport.com/company/invatec-innovative-technologies)
- B.Braun Medical, Inc.: 3 (https://510kreport.com/company/b-braun-medical)
- Respicardia: 3 (https://510kreport.com/company/respicardia)
- Arstasis, Inc.: 3 (https://510kreport.com/company/arstasis)
- Ekos Corp.: 3 (https://510kreport.com/company/ekos)

## Its most-cited devices
- K961794: Fluid Administration Set - Contrast Manager (1996), cited by 6
- K974067: Fountain Infusion  Catheter  and Occluding Guide Wire (1998), cited by 6
- K000659: Modification to Softouch Diagnostic Intravascular Cat (2000), cited by 5
- K053171: Merit Impress Diagnostic Catheter (2006), cited by 5
- K070159: Prelude Sheath Introducer (2007), cited by 5
- K031691: Merit Mak (Mini Access Kit) (2003), cited by 4

## Recent decisions
- K261310: FlexTract Deflectable-Rotational Dilator Sheath Set (Jul 27, 2026)
- K262086: PreludeSYNC™ Radial Compression Device (Jul 22, 2026)
- K254073: StatSeal Disc (May 13, 2026)
- K251802: STAR RF Ablation System (Feb 13, 2026)
- K252892: SCOUT MD Surgical Guidance System (Dec 19, 2025)
- K250853: Merit Syringe (Nov 4, 2025)
- K251265: Resilience Fully Covered Esophageal Stent System (Jul 23, 2025)
- K250909: Prelude Wave Hydrophilic Sheath Introducer (Apr 25, 2025)

Source page: https://510kreport.com/company/merit-medical-systems