# K063681: Tecno-Gaz Andromeda Vacuum CS Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Mediline Italia S.R.L.
- Decided: Jun 29, 2007 after 200 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: 3 generations back to K936181 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023348: Midmark M9 Ultraclave Steam Sterilizer, Midmark Corp. (2003) Summary page 1.
- K003470: Ehs Series Table Top Autoclave, Models 2540 and 3870, Tuttnauer Co., Ltd. (2001) Summary page 1.
- K962903: Prestige Medical Series 2100 Clinical Autoclave, Prestige Medical Corp. (1998) Summary page 1.

## Indications for use
Tecno-Gaz ANDROMEDA VACUUM CS Autoclave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, and other facilities to sterilize heat and moisture-stable, reusable items (including dental hand pieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

Source page: https://510kreport.com/device/K063681
Methodology: https://510kreport.com/methodology