# K072087: Belimed Steam Sterilizer Model Top 5000 Series 24

- Pathway: 510(k) (Traditional)
- Applicant: Belimed Sauter AG
- Decided: Oct 5, 2007 after 67 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: 2 generations back to K964332 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021223: Belimed Steam Sterilizer, Model Top 5000, Sauter AG (2002) Summary page 1.
- 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 24, 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 24, is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer TOP5000, series 24, is available as a single door prevacuum or a double door prevacuum version.

Source page: https://510kreport.com/device/K072087
Methodology: https://510kreport.com/methodology