# K213545: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

- Pathway: 510(k) (Abbreviated)
- Applicant: Steelco S.P.A.
- Decided: Feb 2, 2023 after 451 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 K010865 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183410: AMSCO 600 Steam Sterilizer, STERIS Corporation (2019) Summary page 5.

## Indications for use
The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page. At no time will there be patient contact with the subject device. Please see page 2 for indications for use defining available, preprogrammed cycles.

Source page: https://510kreport.com/device/K213545
Methodology: https://510kreport.com/methodology