# Thermedx, LLC

- Location (FDA's records): Solon, OH
- FDA decisions: 5 (2010–2021): 5 510(k) clearances
- Product codes: HIG (4), GEI (1)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smiths Medical Asd, Inc.: 2 (https://510kreport.com/company/smiths-medical-asd)
- Atc Technologies, Inc.: 1 (https://510kreport.com/company/atc-technologies)
- Genicon, Inc.: 1 (https://510kreport.com/company/genicon)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Acmi Corporation: 1 (https://510kreport.com/company/acmi)
- Arizant Healthcare, Inc.: 1 (https://510kreport.com/company/arizant-healthcare)
- Circon Video: 1 (https://510kreport.com/company/circon-video)

## Firms that cite its devices most
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K172048: FluidSmart (2017), cited by 2
- K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000 (2010), cited by 1
- K133799: Thermedx Fluid Managment System (2014), cited by 1

## Recent decisions
- K210628: X-FLO Fluid Management System (Nov 4, 2021)
- K172048: FluidSmart (Sep 5, 2017)
- K133799: Thermedx Fluid Managment System (Jun 20, 2014)
- K102275: Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240 (Mar 25, 2011)
- K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000 (Jul 23, 2010)

Source page: https://510kreport.com/company/thermedx