# K252307: Getinge GSS67N Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Maquet GmbH (A Getinge Group Company)
- Decided: Jan 22, 2026 after 182 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)
- K172159: Getinge GSS67N Series Steam Sterilizer, Maquet GmbH (2018) Summary page 7.

## 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). List of available cycles: See tables below

Source page: https://510kreport.com/device/K252307
Methodology: https://510kreport.com/methodology