# K172040: Aquilex Fluid Control System AQL-100S

- Pathway: 510(k) (Special)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Feb 5, 2018 after 215 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K950035 (1996). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 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.
- K123732: Hysteroscopy Pump HM6, W.O.M. World of Medicine AG (2013) Summary page 5.

## Recalls of this device
- Jul 17, 2023 · Class II · Z-2629-2023: The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until
- Aug 14, 2019 · Class II · Z-2767-2019: The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

## Indications for use
The Aquilex® Fluid Control System AQL-100S is intended to provide fluid 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.

Source page: https://510kreport.com/device/K172040
Methodology: https://510kreport.com/methodology