# K983679: Statim 5000 Cassette Autoclave

- Pathway: 510(k) (Special)
- Applicant: Scican
- Decided: Jan 4, 1999 after 76 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 5000 Cassette Autoclave with Extended Cassette is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting. The extended cassette will accommodate unwrapped stainless steel instruments of a longer and more complex construction to a weight of up to 1.5 kg. With the addition of the extended cassette, the STATIM 5000 unit will now accommodate longer length rigid scopes of up to 49 cm or 197 The unit will process such instruments at a sterilization cycle of 132 C for 10 minutes.

Source page: https://510kreport.com/device/K983679
Methodology: https://510kreport.com/methodology