510(k) · Cleared
ClearedDolphin II Fluid Management System, Model Dol-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Video · HIG Insufflator, Hysteroscopic
Cleared on Jan 8, 2002 after a 207-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jan 8, 2002
- Review
- 207 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK011876 Dolphin II Fluid Management System, Model Dol-2Circon Video · 2002
- Descendant · cites it directly · 4 of its ownK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- Descendant · 3 generations on · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK251273 Asurys Fluid Management SystemBoston Scientific Corporation · 2026
- Descendant · 4 generations on · 0 of its ownK210628 X-FLO Fluid Management SystemThermedx, LLC · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · cites it directly4descendants
- K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · 2 generations on3descendants
- K172048FluidSmartThermedx, LLC · 2017 · 3 generations on2descendants
- K251273Asurys Fluid Management SystemBoston Scientific Corporation · 2026 · 4 generations on0descendants
- K210628X-FLO Fluid Management SystemThermedx, LLC · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011876 | Dolphin II Fluid Management System, Model Dol-2 | Circon Video | 2002 | — |
| +1 | K091939 | Thermedx Prodigy Fluid Management System, Models P1000, P2000 | Thermedx, LLC | 2010 | 2 |
| +2 | K133799 | Thermedx Fluid Managment System | Thermedx, LLC | 2014 | 2 |
| +3 | K172048 | FluidSmart | Thermedx, LLC | 2017 | 1 |
| +4 | K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026 | — |
| +4 | K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 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?
- Of its descendants, K091939 (Thermedx, LLC, 2010) has gone furthest, with 4 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 DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011876: Dolphin II Fluid Management System, Model Dol-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011876
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026