# K122071: Getinge 400HC-E / Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Getinge Sourcing, LLC
- Decided: Mar 12, 2013 after 239 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: 6 generations back to K820783 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120441: Getinge 700HC-E Series Steam Sterilizer, Getinge Sourcing, LLC (2012) Summary page 1.
- K103504: Getinge 400HC/500HC Series Steam Sterilizer, Getinge Sourcing, LLC (2011) Summary page 1.

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

Source page: https://510kreport.com/device/K122071
Methodology: https://510kreport.com/methodology