510(k) · Cleared
ClearedIur Fluid Management System
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 Aug 13, 2003 as substantially equivalent to K022449 (W.O.M. World of Medicine AG, 2003) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 1995. 15 later devices descend from it.
- Decided
- Aug 13, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K936231 (1995). 5 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK936231 The Karl Storz Hamou EndomatKarl Storz Endoscopy · 1995
- 1 generation backK022449 Hystereoscopy Pump HM4W.O.M. World of Medicine AG · 2003
- This deviceK031616 Iur Fluid Management SystemW.O.M. World of Medicine AG · 2003
- Descendant · cites it directly · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · 2 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 3 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 2 generations on · 2 of its ownK180825 Fluent Fluid Management SystemHologic, Inc. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · cites it directly14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 2 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 3 generations on4descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 2 generations on2descendants
- K180825Fluent Fluid Management SystemHologic, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936231 | The Karl Storz Hamou Endomat | Karl Storz Endoscopy | 1995 | — |
| −1 | K022449 | Hystereoscopy Pump HM4 | W.O.M. World of Medicine AG | 2003 | — |
| 0 (this device) | K031616 | Iur Fluid Management System | W.O.M. World of Medicine AG | 2003 | — |
| +1 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| +2 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| +3 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +2 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +2 | K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022449 | Hystereoscopy Pump HM4Summary page 2…e: The TUR Fluid Management System described in this notification is similar in design and technological characteristics to the Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD OF MEDICINE AG and to the Flo-Stat Fluid Monitoring System 6954775) manufactured by Gyn… | 2003 |
| * | K954775 | Flo-Stat Fluid Monitoring SystemSummary page 1…Predicate Devices: Hysteroscopy Pump H M 4 $022449) manufactured by W.O.M. WORLD OF MEDICINE AG Flo-Stat Fluid Monitoring System (K954775) manufactured by Gynecare Lnnovation Center. V. Intended Use: The IUR Fluid Management System is a syste… | 1996 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112642 | Aquilex Fluid Control System H112 | 2012 | 14 |
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 8 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112642 (W.O.M. World of Medicine AG, 2012) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K022449.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031616: Iur Fluid Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031616
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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