510(k) · Cleared
ClearedStatim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican, Ltd. · FLE Sterilizer, Steam
Cleared on Dec 19, 2007 as substantially equivalent to K962179 (Scican, 1997) after a 106-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Dec 19, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915054 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915054 Statim Cassett Autoclave, ModificationScican · 1992
- 1 generation backK962179 Stat IM 5000 Cassette AutoclaveScican · 1997
- This deviceK072466 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K915054 | Statim Cassett Autoclave, Modification | Scican | 1992 | — |
| −1 | K962179 | Stat IM 5000 Cassette Autoclave | Scican | 1997 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K962179 | Stat IM 5000 Cassette AutoclaveSummary page 1…Name of Device: STAT/M 7000 Cassette Autoclave Predicate Device: STAT/M 5000 Cassette Autoclave 510(k) K962179 Description of Device: The STATIM 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and d… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090670 | Midmark M3 Ultrafast Automatic Sterilizer | 2009 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090670 (Midmark Corp., 2009) has gone furthest, with 0 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. 2007, 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 STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly…
Read the full statement (237 words)
The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection.
The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 1340 C (273 0 F) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, textiles, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual.
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows:
CYCLE — TEMPERATURE — PURGE PURGES — STERILIZATION TIME — INTENDED USE
UNWRAPPED — 134°C (273°F) — 3 — 3.5 mi. — Solid instruments, hinged instruments, dental handpieces, with drying
WRAPPED — 134-C (273°F) — 6 — 3.5 min. — Solid, hollow (including dental handpieces) & hinged instruments wrapped in paper/paper or paper/plastic pouches or paper sterilization wrap, with improved drying performance
RUBBER & PLASTICS — 1210 C (250 0 F). — 330 — min. — Instruments of rubber & plastic construction (exceptions are listed in the Operator's Manual) with drying
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072466: Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072466
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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