510(k) · Cleared
ClearedStatim Cassett Autoclave, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican · FLE Sterilizer, Steam
Cleared on Aug 4, 1992 after a 274-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 4, 1992
- Review
- 274 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK915054 Statim Cassett Autoclave, ModificationScican · 1992
- Descendant · cites it directly · 2 of its ownK962179 Stat IM 5000 Cassette AutoclaveScican · 1997
- Descendant · 2 generations on · 1 of its ownK072466 Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with…Scican, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK090670 Midmark M3 Ultrafast Automatic SterilizerMidmark Corp. · 2009
Most influential descendants
Showing 3 of 3 · See all- K962179Stat IM 5000 Cassette AutoclaveScican · 1997 · cites it directly2descendants
- K072466Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model…Scican, Ltd. · 2007 · 2 generations on1descendant
- K090670Midmark M3 Ultrafast Automatic SterilizerMidmark Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915054 | Statim Cassett Autoclave, Modification | Scican | 1992 | — |
| +1 | K962179 | Stat IM 5000 Cassette Autoclave | Scican | 1997 | — |
| +2 | K072466 | Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port)… | Scican, Ltd. | 2007 | — |
| +1 | K090670 | Midmark M3 Ultrafast Automatic Sterilizer | Midmark Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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? (3)
2 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?
- Of its descendants, K962179 (Scican, 1997) has gone furthest, with 2 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/K915054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915054: Statim Cassett Autoclave, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915054
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026