# K011601: Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX

- Pathway: 510(k) (Traditional)
- Applicant: Ardo Medical AG
- Decided: Jun 8, 2001 after 15 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: 1 generation back to K853917 (1985). 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)
- K853917: Egnell Compact Suction Pump, Egnell, Inc. (1985) Summary page 1.
- K983552: Basic, Median, Dominant, and Vario, Medela, Inc. (1999) Summary page 1.

## Indications for use
The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

Source page: https://510kreport.com/device/K011601
Methodology: https://510kreport.com/methodology