Cleared Traditional

Steam Sterilizer (2545D)

K243994 · Ningbo Ican Machines Co., Ltd. · General Hospital

Jun 2025

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K243994 is an FDA 510(k) clearance for the Steam Sterilizer (2545D), a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Ningbo Ican Machines Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on June 6, 2025, 162 days after receiving the submission on December 26, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K243994 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2024
Decision Date	June 06, 2025
Days to Decision	162 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF