# K103504: Getinge 400HC/500HC Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Getinge Sourcing, LLC
- Decided: Mar 16, 2011 after 110 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: 4 generations back to K820783 (1982). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC, Getinge/Castle, Inc. (2001) Summary page 1.

## Most influential descendants
- K120441: Getinge 700HC-E Series Steam Sterilizer (2012), 2 descendants of its own
- K122625: Getinge 800HC- Series Steam Sterilizer (2013), 0 descendants of its own
- K122071: Getinge 400HC-E / Series Steam Sterilizer (2013), 0 descendants of its own

## Indications for use
The Getinge 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

Source page: https://510kreport.com/device/K103504
Methodology: https://510kreport.com/methodology