# K172159: Getinge GSS67N Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Maquet GmbH
- Decided: Jan 30, 2018 after 196 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.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070657: Getinge 633HC Series Vacuum/Gravity Steam Sterilizer, Getinge Sourcing, LLC (2007) Summary page 6.

## Most influential descendants
- K201927: Getinge GSS610N Series Steam Sterilizer (2021), 1 descendant of its own
- K252307: Getinge GSS67N Series Steam Sterilizer (2026), 0 descendants of its own
- K214120: GSS610N21 Series Steam Sterilizer (2022), 0 descendants of its own

## Indications for use
The Getinge GSS67N 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 GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).

Source page: https://510kreport.com/device/K172159
Methodology: https://510kreport.com/methodology