# K130172: Belimed Steam Sterilizer MST-V

- Pathway: 510(k) (Abbreviated)
- Applicant: Belimed, Inc.
- Decided: Sep 23, 2013 after 242 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 K060337 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100622: Belimed Steam Sterilizer, Model MST-V 3-3-6, Belimed Sauter AG (2010). Our reading of the summary gave K100662, FDA’s number for Femvue Cornual Balloon Catheter (Femasys, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Belimed Steam Sterilizer MST-V Series 3-3-6”.

## Indications for use
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.

Source page: https://510kreport.com/device/K130172
Methodology: https://510kreport.com/methodology