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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 the device name listed in this FDA 510(k) record. The listed applicant is Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) 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. The listed applicant is Sterilucent, Inc.. The 510(k) number is K190005.

When did Sterilucent HC 80TT Hydrogen Peroxide Sterilizer receive FDA 510(k) clearance?

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

Who is the listed applicant for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

The FDA 510(k) record lists Sterilucent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sterilucent, Inc. as applicant

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.

K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge DeviceK191999Sterilucent VH2O2 Chemical Indicators

Related Devices (Code: MLR)

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.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization ProductsK233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris

Official Source

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

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