# K010865: Amsco Century Medium Sterilizer, Model Century

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: May 31, 2001 after 70 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
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020747: Amsco Century Medium Sterilizer 26 X 26 (2002), 17 descendants of its own
- K082435: Amsco Evolution Medium Steam Sterilizer (2008), 8 descendants of its own
- K112403: Amsco Chimeron Medium Steam Sterlilzer (2012), 7 descendants of its own
- K183410: AMSCO 600 Steam Sterilizer (2019), 5 descendants of its own
- K091136: Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 (2009), 4 descendants of its own

## Recalls of this device
- Mar 22, 2007 · Not classified · Z-1193-2007: The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.

Source page: https://510kreport.com/device/K010865
Methodology: https://510kreport.com/methodology