# K112642: Aquilex Fluid Control System H112

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: Feb 6, 2012 after 147 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 K950035 (1996). 26 ancestors in all.
14 later devices descend from it; 5 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)
- K031616: Iur Fluid Management System, W.O.M. World of Medicine AG (2003) Summary page 2.
- K062380: Flosimple Arthroscopy Pump A120, W.O.M. World of Medicine AG (2006) Summary page 2.
- K083211: Airseal Optical Trocar & Cannula System, Surgiquest, Inc. (2008) Summary page 2.
- K936231: The Karl Storz Hamou Endomat, Karl Storz Endoscopy (1995) Summary page 2.

## Most influential descendants
- 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
- K213171: Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (2022), 1 descendant of its own

## Indications for use
The Aquilex Fluid Control System H 112 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroseopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

Source page: https://510kreport.com/device/K112642
Methodology: https://510kreport.com/methodology