510(k) · Cleared
ClearedStatim 2000 G4 Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican, Ltd. · FLE Sterilizer, Steam
Cleared on Jul 10, 2012 after a 284-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 10, 2012
- Review
- 284 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical and dental instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bic-organisms. The units are intended to sterilize heat and moisture stable medical and dental instruments…
Read the full statement (612 words)
The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical and dental instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bic-organisms.
The units are intended to sterilize heat and moisture stable medical and dental instruments (including handpieces) which are commonly found in medical and dental 0ffices, 0hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 134 C (275 F) or 121 C (250 F). The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 2000 G4 Cassette Autoclave are as follows:
CYCLE: UNWRAPPED (for Immediate Use); TEMPERATURE: 1350 C (275-F); STERILIZATION / DRYING TIME: 3.5 min. / 60 min.; MAX LOAD: 1.0 kg (2.2 Ibs); ITEMS: Solid metal instruments, hinged metal instruments, dental and phaco handpieces, with drying.
CYCLE: WRAPPED; TEMPERATURE: 1350 C (275-F); STERILIZATION / DRYING TIME: 10 min. / 60 min.; MAX LOAD: 1.0 kg (2.2 Ibs); ITEMS: Solid, hollow (including dental and phaco handpieces) & hinged metal instruments wrapped in paper/paper or paper/plastic pouches that are cleared by FDA for the claimed cycles, with drying.
CYCLE: RUBBER & PLASTICS; TEMPERATURE: 1210 C (250 0 F); STERILIZATION / DRYING TIME: 15 min. / 60 min.; MAX LOAD: 0.4 kg (0.9 Ibs); ITEMS: Instruments of rubber & plastic construction (exceptions are listed in the Operator's Manual) with drying.
The lumen specifications are as follows:
Dental Handpieces: 7 handpieces within a 1 kg load
Phaco Handpieces: 2 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 5000 G4 Cassette Autoclave are as follows:
CYCLE: UNWRAPPED (for Immediate Use); TEMPERATURE: 132 0C (2700 F); STERILIZATION / DRYING TIME: 3.5 min. / 60 min.; MAX LOAD: 0.5 kg (1.1 Ibs); ITEMS: Solid metal instruments, hinged metal instruments with drying.
CYCLE: WRAPPED; TEMPERATURE: 1320C (270 0F); STERILIZATION / DRYING TIME: 6 min. / 60 min.; MAX LOAD: 1.5 kg (3.3 Ibs); ITEMS: Solid, hollow (including dental and phaco handpieces) & hinged metal instruments wrapped in paper/paper or paper/plastic pouches that are cleared by FDA for the claimed cycles, with drying.
CYCLE: RUBBER & PLASTICS; TEMPERATURE: 12100 (2500 F); STERILIZATION / DRYING TIME: 35 min. / 60 min.; MAX LOAD: 0.4 kg (0.9 Ibs); ITEMS: Instruments of rubber & plastic construction (exceptions are listed in the Operators Manual) with drying.
CYCLE: HEAVY DUTY UNWRAPPED (for Immediate Use); TEMPERATURE: 1320C (270 0 F); STERILIZATION / DRYING TIME: 6 min. / 60 min.; MAX LOAD: 1.5 kg (3.3 Ibs); ITEMS: Solid metal instruments, hinged metal instruments and dental and phaco handpieces with drying. The extended cassette must be used for the processing of longer instruments such as autoclavable rigid endoscopes in this cycle.
The lumen specifications are as follows:
Dental Handpieces: 8 handpieces within a 1.5 kg load
Phaco Handpieces: 5 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08') and maximum length of 190 mm (7.5")
Rigid Endoscopes: 3 scopes, 1 lumen per scope, where the lumens have a minimum inner diameter of 1 mm (0.04') and a maximum length of 490 mm (19")
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112872: Statim 2000 G4 Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112872
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026