# K173485: Amsco Evolution Medium Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 22, 2018 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: 3 generations back to K010865 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082435: Amsco Evolution Medium Steam Sterilizer, STERIS Corporation (2008) Summary page 8.

## Most influential descendants
- 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) (2020), 0 descendants of its own

## Indications for use
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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1): The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2): The following table lists STERIS’s recommended loads by sterilizer size: The following table is a guideline for liquid cycle processing: The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes: • 26”x26”x39” (660 mm x 660 mm x 991 mm), Model HC-600 • 26”x37½”x 60” (660mm x 950mm x 1524mm)

Source page: https://510kreport.com/device/K173485
Methodology: https://510kreport.com/methodology