# K210326: Bravo G4 Chamber Autoclave

- Pathway: 510(k) (Abbreviated)
- Applicant: Scican, Ltd.
- Decided: Jul 1, 2021 after 147 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 BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The BRAVO G4 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 I or damage to the autoclave. A table describing the BRAVO G4 programs, cycle times, temperatures and dry times is available on the next page.

Source page: https://510kreport.com/device/K210326
Methodology: https://510kreport.com/methodology