# K112403: Amsco Chimeron Medium Steam Sterlilzer

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: May 8, 2012 after 260 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: 2 generations back to K010865 (2001). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K183410: AMSCO 600 Steam Sterilizer (2019), 5 descendants of its own
- K211500: AMSCO 600 Medium Steam Sterilizer (2021), 2 descendants of its own
- K222543: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System,  V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 1 descendant of its own
- K213545: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 (2023), 0 descendants of its own
- K222849: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System,  RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 0 descendants of its own

## Recalls of this device
- Feb 12, 2013 · Class II · Z-0915-2013: The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the

## Indications for use
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) 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. The AMSCO Chimeron Medium Prevacuum Steam Sterilizers are equipped with the following factory-programmed sterilization cycles and cycle values (Table A-I):

Source page: https://510kreport.com/device/K112403
Methodology: https://510kreport.com/methodology