# K962179: Stat IM 5000 Cassette Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Scican
- Decided: Jan 13, 1997 after 221 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
Longest line of descent: 1 generation back to K915054 (1992). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915054: Statim Cassett Autoclave, Modification, Scican (1992) Summary page 1.

## Most influential descendants
- K072466: Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101 (2007), 1 descendant of its own
- K090670: Midmark M3 Ultrafast Automatic Sterilizer (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K962179
Methodology: https://510kreport.com/methodology