510(k) · Cleared
ClearedSurgipump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · DQI Withdrawal/Infusion Pump
Cleared on Apr 21, 1994 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Apr 21, 1994
- Review
- 146 days
- Class
- Class II
- Product code
- DQI
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK935763 SurgipumpW.O.M. World of Medicine GmbH · 1994
- Descendant · cites it directly · 17 of its ownK990732 Lap-Wave 3000 (P07)W.O.M. World of Medicine GmbH · 1999
- Descendant · 2 generations on · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- Descendant · 3 generations on · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · 4 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 5 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K990732Lap-Wave 3000 (P07)W.O.M. World of Medicine GmbH · 1999 · cites it directly17descendants
- K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · 2 generations on15descendants
- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 3 generations on14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 4 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935763 | Surgipump | W.O.M. World of Medicine GmbH | 1994 | — |
| +1 | K990732 | Lap-Wave 3000 (P07) | W.O.M. World of Medicine GmbH | 1999 | — |
| +2 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| +3 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| +4 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| +5 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990732 | Lap-Wave 3000 (P07) | 1999 | 17 |
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?
- Of its descendants, K990732 (W.O.M. World of Medicine GmbH, 1999) has gone furthest, with 17 descendants of its own.
How does its category compare?
All DQI devicesDQI Withdrawal/Infusion Pump: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQI
FDA has decided no DQI device since 2007.
Median 510(k) review, days · DQI
Too few DQI 510(k)s in any year since 2007 to give a median.
Recalls per year · DQI
No recall names DQI since 2007.
Adverse event reports per year · DQI
No MAUDE report names DQI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935763: Surgipump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935763
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026