# K031213: Aquasens Fluid Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Apr 30, 2003 after 13 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AquaSens Fluid Monitoring System 3000: named in the summary without a submission number

## Indications for use
The Davol AquaSens Fluid Monitoring System 4000 is intended for use in gynecological surgical and diagnostic procedures. The system consolidates the supply and collection of irrigation fluids used during hysteroscopic procedures to distend the uterus and to clear the operative site of blood and debris. The system monitors irrigation fluid losses/gains and indicates when such losses/gains exceed a level pre-set by the surgeon.

Source page: https://510kreport.com/device/K031213
Methodology: https://510kreport.com/methodology