510(k) · Cleared
ClearedHystereoscopy Pump HM4
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 Apr 10, 2003 as substantially equivalent to K934866 (W.O.M. World of Medicine GmbH, 1995) and 2 other predicates after a 258-day review. Its family tree reaches back 1 generation to 1995. 20 later devices descend from it.
- Decided
- Apr 10, 2003
- Review
- 258 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K936231 (1995). 3 ancestors in all. 20 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK936231 The Karl Storz Hamou EndomatKarl Storz Endoscopy · 1995
- This deviceK022449 Hystereoscopy Pump HM4W.O.M. World of Medicine AG · 2003
- Descendant · cites it directly · 15 of its ownK031616 Iur Fluid Management SystemW.O.M. World of Medicine AG · 2003
- Descendant · 2 generations on · 14 of its ownK112642 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 · 3 of its ownK042457 Uro ProW.O.M. World of Medicine AG · 2004 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K031616Iur Fluid Management SystemW.O.M. World of Medicine AG · 2003 · cites it directly15descendants
- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 2 generations on14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · cites it directly6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 2 generations on4descendants
- K042457Uro ProW.O.M. World of Medicine AG · 2004 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936231 | The Karl Storz Hamou Endomat | Karl Storz Endoscopy | 1995 | — |
| 0 (this device) | K022449 | Hystereoscopy Pump HM4 | W.O.M. World of Medicine AG | 2003 | — |
| +1 | K031616 | Iur Fluid Management System | W.O.M. World of Medicine AG | 2003 | — |
| +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 | — |
| +2 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +1 | K042457 | Uro Pro | W.O.M. World of Medicine AG | 2004 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | K934866 | Hys-SurgimatSummary page 1…Class 11. This device is described in 21 C.F.R. 6 884.1700. The product code for the device is HIG. IV. Predicate Devices: 0 HYS-Surgimat (K934866) manufactured by W.O.M. WORLD OF MEDICINE AG 0 Karl S t o n Model 203020 20 Equimat (K961091) distributed b… | 1995 |
| * | K961091 | Karl Storz Model 203020 20 EquimatSummary page 1…IV. Predicate Devices: 0 HYS-Surgimat (K934866) manufactured by W.O.M. WORLD OF MEDICINE AG 0 Karl S t o n Model 203020 20 Equimat (K961091) distributed by Karl Storz Endoscopy-America, Inc. 0 Karl S t o n Hamou Endomat (K93623 1) distributed by K… | 1996 |
| * | K936231 | The Karl Storz Hamou EndomatSummary page 1…ICINE AG 0 Karl S t o n Model 203020 20 Equimat (K961091) distributed by Karl Storz Endoscopy-America, Inc. 0 Karl S t o n Hamou Endomat (K93623 1) distributed by Karl Storz Endoscopy-America, Inc. V. Intended Use: The Hysteroscopy Pump HM4 is a syste… | 1995 |
What descends from it? (20)
See all 204 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K031616 (W.O.M. World of Medicine AG, 2003) has gone furthest, with 15 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.
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 Hysteroscopy Pump HM4 is a system 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/K022449 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022449: Hystereoscopy Pump HM4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022449
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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