# K203061: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Nov 6, 2020 after 29 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: 5 generations back to K010865 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173481: Amsco Evolution Medium Steam Sterilizer, STERIS Corporation (2018) Summary page 16.
- K173485: Amsco Evolution Medium Steam Sterilizer, STERIS Corporation (2018) Summary page 21.
- K173490: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000), STERIS Corporation (2018) Summary page 26.

## Indications for use
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: * Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. + Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: * Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. » Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: * Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. * Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Source page: https://510kreport.com/device/K203061
Methodology: https://510kreport.com/methodology