# K191896: Belimed Steam Sterilizer MST-H TOP 5000

- Pathway: 510(k) (Abbreviated)
- Applicant: Belimed AG
- Decided: Oct 31, 2019 after 108 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: 3 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)
- K170228: Belimed Steam Sterilizer MST-H TOP 5000, Belimed AG (2017) Summary page 5.

## Indications for use
The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-12 HS2, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the 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/K191896
Methodology: https://510kreport.com/methodology