# K060337: Belimed Steam Sterilizer Top 5000, Model 5-5-9

- Pathway: 510(k) (Special)
- Applicant: Sauter AG
- Decided: Mar 8, 2006 after 26 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 4 - 8: named in the summary without a submission number

## Most influential descendants
- K100622: Belimed Steam Sterilizer, Model MST-V 3-3-6 (2010), 1 descendant of its own
- K130172: Belimed Steam Sterilizer MST-V (2013), 0 descendants of its own

## Indications for use
The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version.

Source page: https://510kreport.com/device/K060337
Methodology: https://510kreport.com/methodology