# K111223: Amsco Chimeron Small Steam Sterilizer

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Sep 20, 2011 after 141 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K820783 (1982). 6 ancestors in all.
3 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)
- K030789: Amsco Century Steam Sterilizer, STERIS Corporation (2003) Summary page 1.

## Most influential descendants
- K221474: PRIMUS Healthcare Sterilizer (Model PSS11-HC) (2023), 1 descendant of its own
- K233132: PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (2023), 0 descendants of its own
- K212424: AMSCO 400 Small Steam Sterilizers,  AMSCO 400 Medium Steam Sterilizers (2021), 0 descendants of its own

## Recalls of this device
- Sep 3, 2015 · Class III · Z-0210-2016: In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close t
- 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
- 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 Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations Prevacuum (Models 16, 16C and 20, 20C) — are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) — are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Source page: https://510kreport.com/device/K111223
Methodology: https://510kreport.com/methodology