# K033538: Belimed Steam Sterilizer Top 5000, Series 4 - 8

- Pathway: 510(k) (Special)
- Applicant: Sauter AG
- Decided: Feb 2, 2004 after 84 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Belimed Steam Sterilizer TOP 5000 Series 9 -18: named in the summary without a submission number

## Most influential descendants
- K103841: Belimed Steam Sterilizer MST-V (2011), 0 descendants of its own
- K090339: Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2 (2009), 0 descendants of its own
- K072087: Belimed Steam Sterilizer Model Top 5000 Series 24 (2007), 0 descendants of its own

## Indications for use
The Belimed Steam Sterilizer TOP 5000, series 4-8, 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 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

Source page: https://510kreport.com/device/K033538
Methodology: https://510kreport.com/methodology