# K040239: Supraflow Console

- Pathway: 510(k) (Traditional)
- Applicant: Neomedix Corp.
- Decided: Feb 17, 2004 after 15 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K832520 (1983). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981703: Ksea Unimat 45, Karl Storz Endoscopy (1998) Summary page 1.
- K984363: XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider System, Xomed, Inc. (1999) Summary page 1.
- K980454: Lysonix Aspiration Pump, Lysonix, Inc. (1998) Summary page 1.

## Most influential descendants
- K080845: Orwell Fluid Collection and Disposal System (2008), 1 descendant of its own
- K090759: Biodrain Streamway Fluid Management System (2009), 0 descendants of its own

## Recalls of this device
- May 28, 2007 · Not classified · Z-0071-2008: Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The 

## Indications for use
The NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.

Source page: https://510kreport.com/device/K040239
Methodology: https://510kreport.com/methodology