510(k) · Cleared
ClearedAquilex Fluid Control System H112
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine AG · HIG Insufflator, Hysteroscopic
Cleared on Feb 6, 2012 as substantially equivalent to K031616 (W.O.M. World of Medicine AG, 2003) and 3 other predicates after a 147-day review. Its family tree reaches back 6 generations to 1996. 14 later devices descend from it.
- Decided
- Feb 6, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K950035 (1996). 26 ancestors in all, the oldest K903419 (1990). 14 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 5 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 4 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 3 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 2 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 1 generation backK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- This deviceK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · cites it directly · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 2 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · cites it directly · 2 of its ownK180825 Fluent Fluid Management SystemHologic, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK213171 Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral)…Meditrina, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · cites it directly6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 2 generations on4descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · cites it directly2descendants
- K180825Fluent Fluid Management SystemHologic, Inc. · 2018 · cites it directly2descendants
- K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −5 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −4 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −3 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −2 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −1 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| 0 (this device) | 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 | — |
| +2 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +1 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +1 | K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018 | — |
| +3 | K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta… | Meditrina, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K031616 | Iur Fluid Management SystemSummary page 2…Special 510(k) Premarket Notification Predicate Devices: JUR Fluid Management System, W.O.M. WORLD OF MEDICINE AG, K031616 FLOSIMPLE Artbroscopy Pump A120, W.O.M. WORLD OF MEDICINE AG, K062380… | 2003 |
| * | K062380 | Flosimple Arthroscopy Pump A120Summary page 2…D OF MEDICINE AG, K031616 FLOSIMPLE Artbroscopy Pump A120, W.O.M. WORLD OF MEDICINE AG, K062380 Flo-Stat Fluid Monitoring System, Gynecare Innovation Center, K08321 1… | 2006 |
| * | K083211 | Airseal Optical Trocar & Cannula SystemSummary page 2…D OF MEDICINE AG, K062380 Flo-Stat Fluid Monitoring System, Gynecare Innovation Center, K08321 1 Karl Storz Hamou Endomat, Karl Storz Endoscopy- America, K936231 Device… | 2008 |
| * | K936231 | The Karl Storz Hamou EndomatSummary page 2…re Innovation Center, K08321 1 Karl Storz Hamou Endomat, Karl Storz Endoscopy- America, K936231 Device Description: The Aquilex Fluid Control System Hi 112 is a microprocessor controlled device that consists of the fo… | 1995 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K123732 (W.O.M. World of Medicine AG, 2013) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112642: Aquilex Fluid Control System H112.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112642
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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