# K172825: MN-111

- Pathway: 510(k) (Traditional)
- Applicant: W&H Sterilization S.R.L.
- Decided: May 30, 2018 after 254 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The W&H Steam Sterilizer MN-111 is designed for pressurized steam sterilization of medical and pouched dental instruments, including dental handpiece, porous and hollow loads. Key program features, including sterilization time, temperature and recommended load type are listed in the following table: Program: Pouches Heavy Load Type of Load and Load weight: Instruments and Dental Handpieces up to 18 lbs Sterilization Temperature: 270° F (132°C) Sterilization Time: 4 minutes Drying Time (recommended): 30 minutes Program: Pouches Medium Load Type of Load and Load weight: Instruments and Dental Handpieces up to 3 lbs Sterilization Temperature: 270° F (132°C) Sterilization Time: 4 minutes Drying Time (recommended): 25 minutes Program: Pouches Large Load Type of Load and Load weight: Instruments and Dental Handpieces up to 6 lbs Sterilization Temperature: 270° F (132°C) Sterilization Time: 4 minutes Drying Time (recommended): 30 minutes Program: Pouches &Wrapped Cassettes Type of Load and Load weight: Instruments and Dental Handpieces up to 11 lbs Sterilization Temperature: 270° F (132°C) Sterilization Time: 4 minutes Drying Time (recommended): 35 minutes Program: Wrapped Cassettes Type of Load and Load weight: Instruments and Dental Handpieces up to 14 lbs Sterilization Temperature: 270° F (132°C) Sterilization Time: 4 minutes Drying Time (recommended): 40 minutes Program: Low Temperature Type of Load and Load weight: Textilies, Up 4.4 lbs, or Instruments and Dental Handpieces Requiring Low Temperature up to 5 lbs. Sterilization Temperature: 250° F (121°C) Sterilization Time: 30 minutes Drying Time (recommended): 30 minutes

Source page: https://510kreport.com/device/K172825
Methodology: https://510kreport.com/methodology