# K214057: STATIM 6000B Vacuum Autoclave

- Pathway: 510(k) (Abbreviated)
- Applicant: Scican, Ltd.
- Decided: Mar 31, 2022 after 94 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 6000B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. A table describing the STATIM 6000B programs, cycle times, temperatures and dry times is available on the next page.

Source page: https://510kreport.com/device/K214057
Methodology: https://510kreport.com/methodology