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FDA 510(k)

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

K-Number: K190005 · 2019-09-13

ApplicantSterilucent, Inc.
Decision Date2019-09-13
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a medical device manufactured by Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K190005. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Sterilucent, Inc.. The 510(k) number is K190005.

When was Sterilucent HC 80TT Hydrogen Peroxide Sterilizer approved by the FDA?

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer received FDA 510(k) clearance on 2019-09-13, under approval number K190005.

What company makes Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is manufactured by Sterilucent, Inc..

What is the FDA product code for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

The FDA product code for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is MLR.

Related Clinical Trials

NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07565350 Local Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts RECRUITING NCT07534865 Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts RECRUITING

Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

Other Devices by Sterilucent, Inc.

K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device K191999Sterilucent VH2O2 Chemical Indicators

Related Devices (Code: MLR)

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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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