# K980454: Lysonix Aspiration Pump

- Pathway: 510(k) (Traditional)
- Applicant: Lysonix, Inc.
- Decided: Mar 18, 1998 after 41 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Aspiration component of the LySonix Ultrasonic Surgical System: named in the summary without a submission number

## Most influential descendants
- K040239: Supraflow Console (2004), 2 descendants of its own
- 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

## Indications for use
The LySonix Aspiration System is intended for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.

Source page: https://510kreport.com/device/K980454
Methodology: https://510kreport.com/methodology