Cleared Traditional

K080420 - RESERT XL HLD HIGH LEVEL DISINFECTANT

K080420 is the FDA 510(k) clearance for RESERT XL HLD HIGH LEVEL DISINFECTANT by STERIS Corporation. It is a Class 2 General Hospital device (product code MED) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K080420 · STERIS Corporation · General Hospital
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Sep 2008
Decision
200d
Days
Class 2
Risk

K080420 is an FDA 510(k) clearance for the RESERT XL HLD HIGH LEVEL DISINFECTANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 2, 2008 after a review of 200 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 STERIS Corporation devices

Submission Details

510(k) Number K080420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2008
Decision Date September 02, 2008
Days to Decision 200 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
71d slower than avg
Panel avg: 129d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 26
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K080420.
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
K101409 · STERIS Corporation · Aug 2010
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
K091022 · STERIS Corporation · Apr 2010
SYSTEM 1.5 STERILE PROCESSING SYSTEM
K090036 · STERIS Corporation · Apr 2010
CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · Advanced Sterilization Products · Feb 2003
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000