Cleared Traditional

Getinge GSS67N Series Steam Sterilizer

K252307 · Maquet GmbH (A Getinge Group Company) · General Hospital

Jan 2026

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K252307 is an FDA 510(k) clearance for the Getinge GSS67N Series Steam Sterilizer, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Maquet GmbH (A Getinge Group Company) (Rastatt De-Bw, DE). The FDA issued a Cleared decision on January 22, 2026, 182 days after receiving the submission on July 24, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K252307 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2025
Decision Date	January 22, 2026
Days to Decision	182 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF