# K212424: AMSCO 400 Small Steam Sterilizers,  AMSCO 400 Medium Steam Sterilizers

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Oct 28, 2021 after 85 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: 6 generations back to K820783 (1982). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111223: Amsco Chimeron Small Steam Sterilizer, STERIS Corporation (2011) Summary page 12.
- K112403: Amsco Chimeron Medium Steam Sterlilzer, STERIS Corporation (2012) Summary page 18.
- K112055: Amsco Chimeron Medium Steam Sterilizer, STERIS Corporation (2011) Summary page 22.

## Indications for use
The Amsco 400 Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: • Prevacuum (Models 16, 16C and 20, 20C) – are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. • Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) – are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The AMSCO 400 Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration: • Prevacuum – equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration: • Prevacuum – equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles

Source page: https://510kreport.com/device/K212424
Methodology: https://510kreport.com/methodology