# K112872: Statim 2000 G4 Cassette

- Pathway: 510(k) (Special)
- Applicant: Scican, Ltd.
- Decided: Jul 10, 2012 after 284 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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")

Source page: https://510kreport.com/device/K112872
Methodology: https://510kreport.com/methodology