510(k) · Cleared
ClearedModification of: Midmark M-11 Ultraclave Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midmark Corp. · FLE Sterilizer, Steam
Cleared on Apr 19, 1999 as substantially equivalent to K936181 (Midmark Corp., 1994) after an 89-day review. Its family tree reaches back 1 generation to 1994. 19 later devices descend from it.
- Decided
- Apr 19, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936181 (1994). 19 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994 · Recalled
- This deviceK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- Descendant · cites it directly · 13 of its ownK023348 Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
- Descendant · 2 generations on · 8 of its ownK050263 Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006
- Descendant · 3 generations on · 6 of its ownK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- Descendant · 4 generations on · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- Descendant · 5 generations on · 1 of its ownK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K023348Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003 · cites it directly13descendants
- K050263Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006 · 2 generations on8descendants
- K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015 · 3 generations on6descendants
- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · 4 generations on2descendants
- K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | 1 |
| 0 (this device) | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| +1 | K023348 | Midmark M9 Ultraclave Steam Sterilizer | Midmark Corp. | 2003 | — |
| +2 | K050263 | Millennium Series, Including Millennium B, B+, B2 and BU | M.O. Com S.R.L. | 2006 | — |
| +3 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| +4 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| +5 | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K936181 | Midmark M-11 Ultraclave Steam SterilizerSummary page 1…-11 Ultraclave Steam Sterilizer with dental handpiece indications for use claims equivalence: Midmark M-11 Ultraclave Steam Sterilizer, cleared for marketing 11/30/94 on K936181 Device Description: The Midmark M-11 Ultraclave Steam Sterilizer uses saturated steam at high pressures and temperatures and to… | 1994 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023348 | Midmark M9 Ultraclave Steam Sterilizer | 2003 | 13 |
| K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) | 2019 | 1 |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D… | 2017 | 1 |
| K992744 | Midmark M4*9 Easyclave Steam Sterilizer | 2000 | 1 |
| K021064 | Quantim 16 Autoclave | 2002 | 0 |
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?
- Its one ancestor has a recall.
- Of its descendants, K023348 (Midmark Corp., 2003) has gone furthest, with 13 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 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…
Read the full statement (252 words)
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.
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/K990189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990189
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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