Maquet GmbH (A Getinge Group Company) · Class II · Cleared Jan 22, 2026
| K-number | K252307 |
| Device name | Getinge GSS67N Series Steam Sterilizer |
| Applicant | Maquet GmbH (A Getinge Group Company) |
| Product code | FLE |
| Device class | Class II |
| Decision date | Jan 22, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.6880 |
The Getinge GSS67N Series Steam Sterilizer is a hospital device designed to sterilize wrapped and unwrapped surgical instruments and linens using pressurized steam. It is available in three models with different chamber lengths (39, 51, and 67 inches) and offers multiple sterilization cycles including pre-vacuum, gravity displacement, and liquid load cycles.
The key difference from the predicate device is an increased validated load capacity for 132°C and 135°C PreVac cycles across all three chamber sizes. Additionally, the software and documentation have been updated to comply with FDA guidance on cybersecurity and device software functions.
ANSI/AAMI ST8:2013/(R)2018 Hospital Steam Sterilizers; ANSI/UL 61010-1 3rd Ed for electrical safety; IEC 61010-2-040:2020 for EMC and electrical safety; IEC 61326-1 Edition 3.0 2020-10 for EMC; FCC 47 CFR 15 and ICES-001 for electromagnetic compliance.
The device has the same intended use, operating principle (saturated steam sterilization), materials of construction, and cycle types as the predicate. Performance testing demonstrates that increased load capacities comply with ANSI/AAMI ST8 standards with complete kill of biological indicators. Software updates address current FDA guidance requirements, and all electrical and electromagnetic safety testing shows compliance.
View the full FDA submission: accessdata.fda.gov