510(k) · Cleared
ClearedStat IM 5000 Cassette Autoclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican · FLE Sterilizer, Steam
Cleared on Jan 13, 1997 as substantially equivalent to K915054 (Scican, 1992) after a 221-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Jan 13, 1997
- Review
- 221 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915054 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915054 Statim Cassett Autoclave, ModificationScican · 1992
- This deviceK962179 Stat IM 5000 Cassette AutoclaveScican · 1997
- Descendant · cites it directly · 1 of its ownK072466 Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with…Scican, Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK090670 Midmark M3 Ultrafast Automatic SterilizerMidmark Corp. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915054 | Statim Cassett Autoclave, Modification | Scican | 1992 | — |
| 0 (this device) | 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 | — |
| +2 | K090670 | Midmark M3 Ultrafast Automatic Sterilizer | Midmark Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K915054 | Statim Cassett Autoclave, ModificationSummary page 1…ign, composition and function to the STATIM Cassette Autoclave manufactured by SciCan, Division of Lux and Zwingenberger. The STAT/M has an approved 510 (k) application (K915054) and is currently being marketed in the USA. The main difference between the two autoclaves is that the STAT/M 5000 sterilization… | 1992 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072466 | Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model… | 2007 | 1 |
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?
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 STAT/M 5000 Cassette Autoclave is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting. The STAT/M 5000 has four microprocessor-controlled, pre-programmed cycles. The first cycle operates at 132 °C for 3.5 minutes and is used for light loads of up to 0.5 kg solid stainless steel instruments free from deep cavities or holes, for example, scalers, forceps or scissors. The second cycle operates at 132…
Read the full statement (169 words)
The STAT/M 5000 Cassette Autoclave is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting. The STAT/M 5000 has four microprocessor-controlled, pre-programmed cycles. The first cycle operates at 132 °C for 3.5 minutes and is used for light loads of up to 0.5 kg solid stainless steel instruments free from deep cavities or holes, for example, scalers, forceps or scissors. The second cycle operates at 132 °C for 6 minutes and is for up to 1.5 kg of stainless steel instruments, such as those described above, and instruments of more complex construction, such as handpieces, wrapped in paper/paper or paper/plastic-film packs. The third cycle operates at 121 °C for 35 minutes and is for up to 0.4 kg of rubber, plastic or heat-sensitive items, for example, plastic mouth mirrors, suction tips or impression trays. The fourth cycle is designed for up to 1.5 kg of unwrapped stainless steel instrtuments, such as those described above, and instruments of more complex construction, such as handpieces.
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/K962179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962179: Stat IM 5000 Cassette Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962179
Report an extraction error
Are you the manufacturer?
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