# K221919: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

- Pathway: 510(k) (Traditional)
- Applicant: Hemodia Sas
- Decided: Mar 9, 2023 after 251 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: 4 generations back to K954465 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203480: DOUBLEFLO system, Hemodia Sas (2021) Summary page 5.

## Indications for use
The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets represents an arthroscopy system using fluid from saline bags (0.9% NaCl). 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/K221919
Methodology: https://510kreport.com/methodology