510(k) · Cleared
ClearedMidmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midmark Corporation · FLE Sterilizer, Steam
Cleared on Apr 4, 2024 as substantially equivalent to K163337 (Midmark Corporation, 2017) after a 195-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Apr 4, 2024
- Review
- 195 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936181 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994 · Recalled
- 3 generations backK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- 2 generations backK023348 Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
- 1 generation backK163337 Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and…Midmark Corporation · 2017
- This deviceK233026 Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerMidmark Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | 1 |
| −3 | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| −2 | K023348 | Midmark M9 Ultraclave Steam Sterilizer | Midmark Corp. | 2003 | — |
| −1 | K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D… | Midmark Corporation | 2017 | — |
| 0 (this device) | K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | 2024 | — |
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 |
|---|---|---|---|
| * | K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D…Summary page 7…Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Midmark Corporation K163337 August 31, 2017 Ritter M9D AutoClave® Automatic Steri… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233026: Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233026
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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