510(k) · Cleared
Recalled · Class II · 2023Aquilex Fluid Control System AQL-100S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · HIG Insufflator, Hysteroscopic
Cleared on Feb 5, 2018 as substantially equivalent to K112642 (W.O.M. World of Medicine AG, 2012) and 1 other predicate after a 215-day review. Its family tree reaches back 8 generations to 1996. It has been recalled 2 times.
- Decided
- Feb 5, 2018
- Review
- 215 days
- Class
- Class II
- Product code
- HIG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K950035 (1996). 28 ancestors in all, the oldest K903419 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 7 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 6 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 5 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 4 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 3 generations backK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- 2 generations backK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- 1 generation backK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- This deviceK172040 Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −7 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −6 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −5 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −4 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −3 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| −2 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| −1 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| 0 (this device) | K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIG device
- #1 K261706 Endomat Select (UP220)score 14.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112642 | Aquilex Fluid Control System H112Summary page 4…Product Code: HIG Predicate Devices: Primary Predicate Device: Trade Name: Aquilex Fluid Control System H112 510(k) Number: K112642 Applicant: W.O.M. WORLD OF MEDICINE GmbH Regulation Number: 21 CFR 884.1700 Regulatory Class:… | 2012 |
| * | K123732 | Hysteroscopy Pump HM6Summary page 5…Special 510(k) Premarket Notification Secondary Predicate Device: Trade Name: Hysteroscopy Pump HM6 510(k) Number: K123732 Applicant: W.O.M. WORLD OF MEDICINE GmbH Regulation Number: 21 CFR 884.1700 Regulatory Cl… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2023 | Class II | Z-2629-2023 | Software design | 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 0 ml is reached and may result in… |
| Aug 14, 2019 | Class II | Z-2767-2019 | Nonconforming Material/Component | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 28 ancestors have a recall of any class.
- 4 other devices also cite its predicate K112642.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172040: Aquilex Fluid Control System AQL-100S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172040
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026