# K214120: GSS610N21 Series Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Maquet GmbH
- Decided: May 18, 2022 after 139 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: 7 generations back to K820783 (1982). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201927: Getinge GSS610N Series Steam Sterilizer, Maquet GmbH (2021) Summary page 5.

## Indications for use
The Getinge GSS610N21 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. Please see "GSS610N Load chart table" (1 page) as attachment to this form.

Source page: https://510kreport.com/device/K214120
Methodology: https://510kreport.com/methodology