# Hemodia Sas

- Location (FDA's records): Labege, FR
- FDA decisions: 4 (2013–2023): 4 510(k) clearances
- Product codes: HRX (4)
- 510(k) review time since 2016: median 251 days, against 141 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 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
- Future Medical Systems, Inc.: 3 (https://510kreport.com/company/future-medical-systems)
- Orthoconcept, Inc.: 1 (https://510kreport.com/company/orthoconcept)
- Depuy Mitek, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)

## Its most-cited devices
- K192921: Zeos Aqua Vision Pump and tube (2020), cited by 1
- K203480: DOUBLEFLO system (2021), cited by 1

## Recent decisions
- K221919: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (Mar 9, 2023)
- K203480: DOUBLEFLO system (Apr 5, 2021)
- K192921: Zeos Aqua Vision Pump and tube (Oct 9, 2020)
- K132883: Hemodia Arthroscopy Pump Tube Sets (Hats) (Nov 1, 2013)

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