Cleared Traditional

K091022 - MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT

K091022 is an FDA 510(k) clearance for MODIFICATION TO RESERT XL HLD HIGH LEVE..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K091022 · STERIS Corporation · General Hospital
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Apr 2010
Decision
368d
Days
Class 2
Risk

K091022 is an FDA 510(k) clearance for the MODIFICATION TO 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 April 12, 2010 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K091022

510(k) Number K091022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date April 12, 2010
Days to Decision 368 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
239d slower than avg
Panel avg: 129d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K091022.
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