# K172048: FluidSmart

- Pathway: 510(k) (Special)
- Applicant: Thermedx, LLC
- Decided: Sep 5, 2017 after 61 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K873435 (1987). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133799: Thermedx Fluid Managment System, Thermedx, LLC (2014) Summary page 5.
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,, Smiths Medical Asd, Inc. (2008) Summary page 5.

## Most influential descendants
- K251273: Asurys Fluid Management System (2026), 0 descendants of its own
- K210628: X-FLO Fluid Management System (2021), 0 descendants of its own

## Recalls of this device
- Apr 9, 2026 · Class II · Z-2166-2026: Due to nonconforming products being inadvertently distributed.

## Indications for use
Intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

Source page: https://510kreport.com/device/K172048
Methodology: https://510kreport.com/methodology