Cleared Traditional

K190005 - Sterilucent HC 80TT Hydrogen Peroxide S...

K190005 is the FDA 510(k) clearance for Sterilucent HC 80TT Hydrogen Peroxide S... by Sterilucent, Inc.. It is a Class 2 General Hospital device (product code MLR) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K190005 · Sterilucent, Inc. · General Hospital
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Sep 2019
Decision
254d
Days
Class 2
Risk

K190005 is an FDA 510(k) clearance for the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Sterilucent, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 13, 2019 after a review of 254 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterilucent, Inc. devices

Submission Details

510(k) Number K190005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2019
Decision Date September 13, 2019
Days to Decision 254 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 129d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLR Sterilizer, Chemical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MLR Sterilizer, Chemical

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