# K023348: Midmark M9 Ultraclave Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corp.
- Decided: Mar 3, 2003 after 147 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 K936181 (1994). 2 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer, Midmark Corp. (1999) Summary page 1.

## Most influential descendants
- K050263: Millennium Series, Including Millennium B, B+, B2 and BU (2006), 8 descendants of its own
- K143311: Pre-vacuum Tabletop Autoclave (2015), 6 descendants of its own
- K213080: T-Edge 10, T-Edge 11 (2022), 2 descendants of its own
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own
- K163337: Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (2017), 1 descendant of its own

## Indications for use
The M9 UltraClaveTM is intended to 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/K023348
Methodology: https://510kreport.com/methodology