# K092903: Bora UP 2080, Bora UP 2080 OP and Bora UP 2080 Mounting

- Pathway: 510(k) (Traditional)
- Applicant: Maquet GmbH and Co. KG
- Decided: Dec 1, 2009 after 71 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
Longest line of descent: 2 generations back to K021368 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042943: Nouvag AG - Vacuson 40 and Vacuson 60, Nouvag AG (2004) Summary page 1.

## Indications for use
The Born UP 2080, BORA UP 2080 OP and DORA UP 2080 MOUNTING are intended as extraction suction units for aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.

Source page: https://510kreport.com/device/K092903
Methodology: https://510kreport.com/methodology