# K090759: Biodrain Streamway Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Biodrain Medical, Inc.
- Decided: Apr 1, 2009 after 9 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K832520 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080845: Orwell Fluid Collection and Disposal System, Cardinalhealth (2008) Summary page 1.
- K012991: Neptune Waste Management Ststem, Stryker Instruments (2001) Summary page 1.

## Indications for use
The BinDrain STREAMWAYrM Fluid Management System (FMS) is intended to be used in areas such as Operating Rooms, Intensive Care Units, Pathology Suites, Emergency Rooms, Surgical Centers and Doctors' Offices to collect and dispose of fluid waste.

Source page: https://510kreport.com/device/K090759
Methodology: https://510kreport.com/methodology