# K981703: Ksea Unimat 45

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Aug 12, 1998 after 90 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 no predicate by 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
These instruments are intended for use by qualified surgeons and provide aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures.

Source page: https://510kreport.com/device/K981703
Methodology: https://510kreport.com/methodology