510(k) · Cleared
ClearedMillennium Series, Including Millennium B, B+, B2 and BU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.O. Com S.R.L. · FLE Sterilizer, Steam
Cleared on Nov 21, 2006 as substantially equivalent to K022816 (A-Dec, Inc., 2003) and 1 other predicate after a 655-day review. Its family tree reaches back 3 generations to 1994. 8 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 655 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K936181 (1994). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994 · Recalled
- 2 generations backK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- 1 generation backK023348 Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
- This deviceK050263 Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006
- Descendant · cites it directly · 6 of its ownK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK151597 Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016
- Descendant · 4 generations on · 0 of its ownK250168 Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015 · cites it directly6descendants
- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · 2 generations on2descendants
- K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023 · 3 generations on1descendant
- K151597Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016 · cites it directly1descendant
- K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | 1 |
| −2 | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| −1 | K023348 | Midmark M9 Ultraclave Steam Sterilizer | Midmark Corp. | 2003 | — |
| 0 (this device) | K050263 | Millennium Series, Including Millennium B, B+, B2 and BU | M.O. Com S.R.L. | 2006 | — |
| +1 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| +2 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| +3 | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
| +1 | K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016 | — |
| +4 | K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022816 | W & H Lisa Steam SterilizerSummary page 1…Classification: 880.6880 FLE: Sterilizer, Steam Devices to which the Millennium series claims equivalence: W&LI Lisa (510O(k) number K0228 16) Midmark M19 UiltraClave (510(k) number K023348) Device Description MILLENNIUM series are soph… | 2003 |
| * | K023348 | Midmark M9 Ultraclave Steam SterilizerSummary page 1…the Millennium series claims equivalence: W&LI Lisa (510O(k) number K0228 16) Midmark M19 UiltraClave (510(k) number K023348) Device Description MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different de… | 2003 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K143311 (Tuttnauer U.S.A Co, Ltd., 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050263: Millennium Series, Including Millennium B, B+, B2 and BU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050263
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026