# K163337: Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corporation
- Decided: Aug 31, 2017 after 276 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 K936181 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023348: Midmark M9 Ultraclave Steam Sterilizer, Midmark Corp. (2003) Summary page 7.
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer, Midmark Corp. (1999) Summary page 7.

## Most influential descendants
- K233026: Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (2024), 0 descendants of its own

## Indications for use
The Midmark and Ritter M9 and M11 UltraClave Automatic Sterilizers and the Ritter M9D AutoClave Automatic Sterilizer can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters on the following page for detailed information.

Source page: https://510kreport.com/device/K163337
Methodology: https://510kreport.com/methodology