# K994314: Castle Series 100HC Steam Sterilizers

- Pathway: 510(k) (Special)
- Applicant: Getinge/Castle, Inc.
- Decided: Feb 16, 2000 after 56 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K820783 (1982). 2 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970907: Castle Series 100 Steam Sterilizers (Straightline), Getinge/Castle, Inc. (1997) Summary page 1.

## Most influential descendants
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC (2001), 21 descendants of its own
- K030789: Amsco Century Steam Sterilizer (2003), 8 descendants of its own
- K070657: Getinge 633HC Series Vacuum/Gravity Steam Sterilizer (2007), 5 descendants of its own
- K172159: Getinge GSS67N Series Steam Sterilizer (2018), 3 descendants of its own
- K111223: Amsco Chimeron Small Steam Sterilizer (2011), 3 descendants of its own

## Indications for use
Castle® Series 100HC Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

Source page: https://510kreport.com/device/K994314
Methodology: https://510kreport.com/methodology