# K080845: Orwell Fluid Collection and Disposal System

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Apr 30, 2008 after 35 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: 4 generations back to K832520 (1983). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012991: Neptune Waste Management Ststem, Stryker Instruments (2001) Summary page 1.
- K040239: Supraflow Console, Neomedix Corp. (2004) Summary page 1.

## Most influential descendants
- K090759: Biodrain Streamway Fluid Management System (2009), 0 descendants of its own

## Indications for use
The ORwell TM Fluid Collection and Disposal System is intended to be used in the Operating Rooms, Surgical Centers, and Doctors' Offices to collect and dispose of fluid waste.

Source page: https://510kreport.com/device/K080845
Methodology: https://510kreport.com/methodology