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FDA 510(k)

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

K-Number: K192001 · 2019-10-22

ApplicantSterilucent, Inc.
Decision Date2019-10-22
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is a medical device manufactured by Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-10-22 under approval number K192001. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is a medical device that received FDA 510(k) clearance on 2019-10-22. It is manufactured by Sterilucent, Inc.. The 510(k) number is K192001.

When was Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device approved by the FDA?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device received FDA 510(k) clearance on 2019-10-22, under approval number K192001.

What company makes Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is manufactured by Sterilucent, Inc..

What is the FDA product code for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

The FDA product code for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is FRC.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 42043129 Iatrogenic Microplastic Exposure: A Possible and Underrecognized Healthcare-Associated Exposure Framework in Human Medicotoxicological Risk. Toxics (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026)

Other Devices by Sterilucent, Inc.

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Related Devices (Code: FRC)

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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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