510(k) · Cleared
ClearedMidmark M3 Ultrafast Automatic 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 Jul 7, 2009 as substantially equivalent to K915054 (Scican, 1992) and 1 other predicate after a 116-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jul 7, 2009
- Review
- 116 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915054 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK915054 Statim Cassett Autoclave, ModificationScican · 1992
- 2 generations backK962179 Stat IM 5000 Cassette AutoclaveScican · 1997
- 1 generation backK072466 Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with…Scican, Ltd. · 2007
- This deviceK090670 Midmark M3 Ultrafast Automatic SterilizerMidmark Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915054 | Statim Cassett Autoclave, Modification | Scican | 1992 | — |
| −2 | K962179 | Stat IM 5000 Cassette Autoclave | Scican | 1997 | — |
| −1 | K072466 | Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port)… | Scican, Ltd. | 2007 | — |
| 0 (this device) | K090670 | Midmark M3 Ultrafast Automatic Sterilizer | Midmark Corp. | 2009 | — |
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 |
|---|---|---|---|
| * | K915054 | Statim Cassett Autoclave, ModificationSummary page 1…alence: Company: SciCan, Inc. Product: STATIM2000 510(k): K915054 Claimed equivalence w/ Company: SciCan, Inc. respect to performance wi Product: STATIM 700… | 1992 |
| * | K072466 | Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model…Summary page 1…lence w/ Company: SciCan, Inc. respect to performance wi Product: STATIM 7000 similar cycle parameters: 510(k): K072466 Device Description: The M3 UltraFastTm Automatic Sterilizer is a small table -top steam sterilizer that uses saturated steam… | 2007 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K915054.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 M3 UltraFast™ Automatic Sterilizer can be used in medical, dental, and veterinary 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, in Table-I, on the following page, for detailed information:
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/K090670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090670: Midmark M3 Ultrafast Automatic Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090670
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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