# K120441: Getinge 700HC-E Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Getinge Sourcing, LLC
- Decided: May 31, 2012 after 108 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: 5 generations back to K820783 (1982). 5 ancestors in all.
2 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)
- K103504: Getinge 400HC/500HC Series Steam Sterilizer, Getinge Sourcing, LLC (2011) Summary page 1.

## Most influential descendants
- 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 700HC-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 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length;, 733HC-E 39 inch chamber. 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.

Source page: https://510kreport.com/device/K120441
Methodology: https://510kreport.com/methodology