# K122625: Getinge 800HC- Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Getinge Sourcing, LLC
- Decided: May 22, 2013 after 267 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)

## Indications for use
The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The 80011C-E Series Steam Sterilizer is available in 2 models differentiated by chamber length; 833HC-E 42 inch chamber and 833HC-E 76 inch chamber.

Source page: https://510kreport.com/device/K122625
Methodology: https://510kreport.com/methodology