Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Ningbo Ican Machines Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under approval 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. It is manufactured by Ningbo Ican Machines Co., Ltd.. The 510(k) number is K243994.

When was Steam Sterilizer (2545D) approved by the FDA?

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

What company makes Steam Sterilizer (2545D)?

Steam Sterilizer (2545D) is manufactured by Ningbo Ican Machines Co., Ltd..

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

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

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

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.

↑