# K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corp.
- Decided: Apr 19, 1999 after 89 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: 1 generation back to K936181 (1994). 1 ancestor in all.
19 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936181: Midmark M-11 Ultraclave Steam Sterilizer, Midmark Corp. (1994) Summary page 1.

## Most influential descendants
- K023348: Midmark M9 Ultraclave Steam Sterilizer (2003), 13 descendants of its own
- 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

## Indications for use
The M-11 UltraClave 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 equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters below for detailed information. Standard Cycle Parameters Cycle Temp/Press/Time | Items to be Sterilized (minimums) (Always consult the item manufacturer’s recommendations for sterilization.) Unwrapped | 132°C (270°F)/ 186 kPa (27 psi) | 3 minutes | Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment. Pouches 132°C (270°F)/ 186 kPa (27 psi) | 15 minutes | Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instrtuments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes. Liquids 121°C (250°F)/ 104 kPa (15 psi) | 30 minutes | Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact. Packs 121°C (250°F)/ 104 kPa (15 psi) | 30 minutes | Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes.

Source page: https://510kreport.com/device/K990189
Methodology: https://510kreport.com/methodology