Sterilucent HC 80TT Hydrogen Peroxide Sterilizer— 510(k) K190005

Substantially Equivalent

Sterilucent, Inc.

FDA 510(k) clearance K190005 for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer, Substantially Equivalent on 2019-09-13. Applicant: Sterilucent, Inc..

Clearance details

Applicant: Sterilucent, Inc.
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2019-01-02
Decision date: 2019-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MLR

product code MLR

Malfunction: 805
Total: 805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.