# K031616: Iur Fluid Management System

- Pathway: 510(k) (Special)
- Applicant: W.O.M. World of Medicine AG
- Decided: Aug 13, 2003 after 82 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: 2 generations back to K936231 (1995). 5 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022449: Hystereoscopy Pump HM4, W.O.M. World of Medicine AG (2003) Summary page 2.
- K954775: Flo-Stat Fluid Monitoring System, Gynecare Innovation Center (1996) Summary page 1.

## Most influential descendants
- K112642: Aquilex Fluid Control System H112 (2012), 14 descendants of its own
- K123732: Hysteroscopy Pump HM6 (2013), 6 descendants of its own
- K190372: Aveta System (2019), 4 descendants of its own
- K180735: Endomat Select (2018), 2 descendants of its own
- K180825: Fluent Fluid Management System (2018), 2 descendants of its own

## Indications for use
The IUR Fluid Management System is a device intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

Source page: https://510kreport.com/device/K031616
Methodology: https://510kreport.com/methodology