# K082435: Amsco Evolution Medium Steam Sterilizer

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Dec 30, 2008 after 130 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010865 (2001). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010865: Amsco Century Medium Sterilizer, Model Century, STERIS Corporation (2001) Summary page 2.
- K020747: Amsco Century Medium Sterilizer 26 X 26, STERIS Corporation (2002) Summary page 2.

## Most influential descendants
- K091136: Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 (2009), 4 descendants of its own
- K091731: Amsco Evolution Medium Steam Sterilizer (2009), 2 descendants of its own
- K173481: Amsco Evolution Medium Steam Sterilizer (2018), 1 descendant of its own
- K173485: Amsco Evolution Medium Steam Sterilizer (2018), 1 descendant of its own
- K173490: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (2018), 1 descendant 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
- Dec 26, 2018 · Class II · Z-0824-2019: The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falli
- Oct 18, 2013 · Class II · Z-0478-2014: The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
- Mar 23, 2012 · Not classified · Z-1522-2012: Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer ca

## 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.

Source page: https://510kreport.com/device/K082435
Methodology: https://510kreport.com/methodology