510(k) · Cleared
Recalled · 2011Midmark 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 Nov 30, 1994 after a 338-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it. It has been recalled once.
- Decided
- Nov 30, 1994
- Review
- 338 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 1
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994
- Descendant · cites it directly · 19 of its ownK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- Descendant · 2 generations on · 13 of its ownK023348 Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
- Descendant · 3 generations on · 8 of its ownK050263 Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006
- Descendant · 4 generations on · 6 of its ownK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- Descendant · 5 generations on · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K990189Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999 · cites it directly19descendants
- K023348Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003 · 2 generations on13descendants
- K050263Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006 · 3 generations on8descendants
- K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015 · 4 generations on6descendants
- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | — |
| +1 | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| +2 | K023348 | Midmark M9 Ultraclave Steam Sterilizer | Midmark Corp. | 2003 | — |
| +3 | K050263 | Millennium Series, Including Millennium B, B+, B2 and BU | M.O. Com S.R.L. | 2006 | — |
| +4 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| +5 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | 1999 | 19 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2011 | Not classified | Z-0597-2012 | Employee error | During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990189 (Midmark Corp., 1999) has gone furthest, with 19 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 | — |
https://510kreport.com/device/K936181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936181: 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/K936181
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026