# K110852: Dolphin 3 Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jul 19, 2011 after 113 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
Longest line of descent: 1 generation back to K011876 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011876: Dolphin II Fluid Management System, Model Dol-2, Circon Video (2002)

## Indications for use
The DOLPHIN® 3 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/K110852
Methodology: https://510kreport.com/methodology