# K203480: DOUBLEFLO system

- Pathway: 510(k) (Traditional)
- Applicant: Hemodia Sas
- Decided: Apr 5, 2021 after 129 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954465 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192921: Zeos Aqua Vision Pump and tube, Hemodia Sas (2020) Summary page 5.

## Most influential descendants
- K221919: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (2023), 0 descendants of its own

## Indications for use
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCI). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip. elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.

Source page: https://510kreport.com/device/K203480
Methodology: https://510kreport.com/methodology