# K013585: Mediport 2000 Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Servox Medizintechnik GmbH
- Decided: Jan 28, 2002 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The. Mediport 2000 suction device can be generally used 1n the ENT sector and 1is equally suitable for laryngectomy and tracheostomy patients. It can be used for both in-patient and outpatient purposes. The device is designed for use 1in the event of heavy secretion in the nose, mouth and windpipe after laryngectomies or other operations 1n the mouth and throut area. The Mediport 2000 mobile may only be used for the applications listed above.

Source page: https://510kreport.com/device/K013585
Methodology: https://510kreport.com/methodology