# Merit Medical System, Inc.

- Location (FDA's records): South Jordan, UT
- FDA decisions: 5 (2020–2025): 5 510(k) clearances
- Product codes: DQX (1), NEU (1), KRA (1), QJH (1), KRD (1)
- 510(k) review time since 2016: median 105 days, against 120 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Covidien: 1 (https://510kreport.com/company/covidien)
- Cianna Medical, Inc.: 1 (https://510kreport.com/company/cianna-medical)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Bluegrass Vascular Technologies, Inc.: 1 (https://510kreport.com/company/bluegrass-vascular-technologies)
- Ka Medical, LLC: 1 (https://510kreport.com/company/ka-medical)

## Firms that cite its devices most
- Merit Medical Systems, Inc.: 2 (https://510kreport.com/company/merit-medical-systems)

## Its most-cited devices
- K231468: SCOUT MD Surgical Guidance System (2024), cited by 1
- K212817: Merit Siege Vascular Plug (2021), cited by 1

## Recent decisions
- K252527: Surfacer Inside-Out Access Catheter System (Sep 10, 2025)
- K231468: SCOUT MD Surgical Guidance System (Feb 12, 2024)
- K230636: Maestro Microcatheter (Mar 30, 2023)
- K212817: Merit Siege Vascular Plug (Dec 15, 2021)
- K193571: Go2Wire Guide Wire (Apr 8, 2020)

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