# K180825: Fluent Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Aug 3, 2018 after 126 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: 7 generations back to K950035 (1996). 38 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112642: Aquilex Fluid Control System H112, W.O.M. World of Medicine AG (2012) Summary page 4.
- K172566: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices, Hologic, Inc. (2017) Summary page 4.

## Most influential descendants
- K240886: Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (2024), 0 descendants of its own
- K233710: Symphion Operative Hysteroscopy System (2024), 0 descendants of its own

## Indications for use
The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

Source page: https://510kreport.com/device/K180825
Methodology: https://510kreport.com/methodology