# K210628: X-FLO Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Thermedx, LLC
- Decided: Nov 4, 2021 after 247 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K873435 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172048: FluidSmart, Thermedx, LLC (2017) Summary page 4.

## Indications for use
The X-FLO Fluid Management System is intended to: • Warm and pump fluid, via intravenous (IV) bags or fluid bottles, to provide fluid distention and flushing of the uterus for gynecology procedures. The device can also measure fluid deficit of the surgical procedure. • Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the bladder and kidneys, or general distention and flushing, for urological procedures. The device can also measure fluid deficit of the surgical procedure. • Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the shoulder, knee, or other small joints for orthopedic procedures. The device can also measure fluid deficit of the surgical procedure.

Source page: https://510kreport.com/device/K210628
Methodology: https://510kreport.com/methodology