# K170228: Belimed Steam Sterilizer MST-H TOP 5000

- Pathway: 510(k) (Abbreviated)
- Applicant: Belimed AG
- Decided: May 12, 2017 after 107 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). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K021223: Belimed Steam Sterilizer, Model Top 5000, Sauter AG (2002) Summary page 5.

## Most influential descendants
- K191896: Belimed Steam Sterilizer MST-H TOP 5000 (2019), 0 descendants of its own

## Indications for use
The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities. The Belimed Steam Sterilizer MST-H TOP 5000 is equipped with the following factory programmed sterilization cycles and cycle values. This is shown in Table 1.

Source page: https://510kreport.com/device/K170228
Methodology: https://510kreport.com/methodology