# K011876: Dolphin II Fluid Management System, Model Dol-2

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Jan 8, 2002 after 207 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000 (2010), 4 descendants of its own
- K133799: Thermedx Fluid Managment System (2014), 3 descendants of its own
- K172048: FluidSmart (2017), 2 descendants of its own
- K251273: Asurys Fluid Management System (2026), 0 descendants of its own
- K210628: X-FLO Fluid Management System (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K011876
Methodology: https://510kreport.com/methodology