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FDA 510(k)

Steam Sterilizer (2545D)

K-Number: K243994 · 2025-06-06

ApplicantNingbo Ican Machines Co., Ltd.
Decision Date2025-06-06
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steam Sterilizer (2545D) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Ican Machines Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K243994. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steam Sterilizer (2545D)?

Steam Sterilizer (2545D) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Ningbo Ican Machines Co., Ltd.. The 510(k) number is K243994.

When did Steam Sterilizer (2545D) receive FDA 510(k) clearance?

Steam Sterilizer (2545D) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K243994.

Who is the listed applicant for Steam Sterilizer (2545D)?

The FDA 510(k) record lists Ningbo Ican Machines Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steam Sterilizer (2545D)?

The FDA product code for Steam Sterilizer (2545D) is FLE.

Related Devices (Code: FLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243801FRONT-LINE Field Sterilizer (FL135)Fort Defiance Industries, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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