# K090265: Bravo Autoclave, Models 17, 17V and 21V

- Pathway: 510(k) (Abbreviated)
- Applicant: Scican, Ltd.
- Decided: May 15, 2009 after 101 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: 4 generations back to K936181 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050263: Millennium Series, Including Millennium B, B+, B2 and BU, M.O. Com S.R.L. (2006) Summary page 1.

## Indications for use
The BRAVO series of Autoclaves are table-top vacuum autoclaves that are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process. Typical users of this system are trained professionals including, but not limited to, dentists, nurses, doctors, infection control and re-processing personnel. The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products.

Source page: https://510kreport.com/device/K090265
Methodology: https://510kreport.com/methodology