Cleared Traditional

K190005 - Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

K190005 is an FDA 510(k) clearance for Sterilucent HC 80TT Hydrogen Peroxide S..., manufactured by Sterilucent, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K190005

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.

MLR Device Classification - Class 2, Special Controls

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.

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All 45
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