# K201927: Getinge GSS610N Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Maquet GmbH
- Decided: Mar 1, 2021 after 234 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.
1 later device descends from it; 1 cites 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)
- K172159: Getinge GSS67N Series Steam Sterilizer, Maquet GmbH (2018) Summary page 5.

## Most influential descendants
- K214120: GSS610N21 Series Steam Sterilizer (2022), 0 descendants of its own

## Indications for use
The Getinge GSS610N 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 GSS610N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS610N Model 610N10 (40.9 inch chamber), GSS610N Model 610N14 (51.1 inch chamber), and GSS610N Model 610N15 (60.6 inch chamber).

Source page: https://510kreport.com/device/K201927
Methodology: https://510kreport.com/methodology