# K091731: Amsco Evolution Medium Steam Sterilizer

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Sep 17, 2009 after 98 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 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 2.

## Most influential descendants
- K173490: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (2018), 1 descendant of its own
- 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

## Recalls of this device
- Oct 22, 2019 · Class II · Z-0586-2020: The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpected

## Indications for use
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/K091731
Methodology: https://510kreport.com/methodology