# K050263: Millennium Series, Including Millennium B, B+, B2 and BU

- Pathway: 510(k) (Abbreviated)
- Applicant: M.O. Com S.R.L.
- Decided: Nov 21, 2006 after 655 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). 4 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022816: W & H Lisa Steam Sterilizer, A-Dec, Inc. (2003) Summary page 1.
- K023348: Midmark M9 Ultraclave Steam Sterilizer, Midmark Corp. (2003) Summary page 1.

## Most influential descendants
- 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
- K151597: Family of Steam Sterilizers B 28 series (2016), 1 descendant of its own
- K250168: Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (2025), 0 descendants of its own

## Indications for use
The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. Typical users of this system are trained professionals including, but not limited to, dentists, nurses and other specific medical professionals. NOTE: The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. Also see the "Table of the Available Programs", one for each model, on the next pages.

Source page: https://510kreport.com/device/K050263
Methodology: https://510kreport.com/methodology