# K112055: Amsco Chimeron Medium Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 16, 2011 after 150 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010865 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K212424: AMSCO 400 Small Steam Sterilizers,  AMSCO 400 Medium Steam Sterilizers (2021), 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
- Feb 19, 2015 · Class II · Z-1561-2015: STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a pr

## Indications for use
The AMSCO Chimeron Medium Steam Sterilizers (Models 36H, 48H, 60H, 365L, 48SL, 605L, 36CH, 48CH, 60CH, 36C5L, 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/K112055
Methodology: https://510kreport.com/methodology