# K954775: Flo-Stat Fluid Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Innovation Center
- Decided: May 10, 1996 after 206 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031616: Iur Fluid Management System (2003), 15 descendants of its own
- K112642: Aquilex Fluid Control System H112 (2012), 14 descendants of its own
- K123732: Hysteroscopy Pump HM6 (2013), 6 descendants of its own
- K190372: Aveta System (2019), 4 descendants of its own
- K180735: Endomat Select (2018), 2 descendants of its own

Source page: https://510kreport.com/device/K954775
Methodology: https://510kreport.com/methodology