# K090339: Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2

- Pathway: 510(k) (Traditional)
- Applicant: Belimed Sauter AG
- Decided: Sep 23, 2009 after 225 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- 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 K033538 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033538: Belimed Steam Sterilizer Top 5000, Series 4 - 8, Sauter AG (2004) Summary page 1.

## Indications for use
The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factory-programmed Sterilization cycles and values (Tables 1-3).

Source page: https://510kreport.com/device/K090339
Methodology: https://510kreport.com/methodology