510(k) · Cleared
ClearedFlo-Stat Fluid Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynecare Innovation Center · HET Laparoscope, Gynecologic (And Accessories)
Cleared on May 10, 1996 after a 206-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it.
- Decided
- May 10, 1996
- Review
- 206 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK954775 Flo-Stat Fluid Monitoring SystemGynecare Innovation Center · 1996
- 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 · 3 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 4 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · 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 · 3 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 4 generations on4descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954775 | Flo-Stat Fluid Monitoring System | Gynecare Innovation Center | 1996 | — |
| +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 | — |
| +3 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| +4 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +3 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031616 | Iur Fluid Management System | 2003 | 15 |
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, K031616 (W.O.M. World of Medicine AG, 2003) has gone furthest, with 15 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954775: Flo-Stat Fluid Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954775
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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