Cleared Traditional

K032959 - CIDEX OPA CONCENTRATE

K032959 is the FDA 510(k) clearance for CIDEX OPA CONCENTRATE by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code MED) cleared through the Traditional 510(k) pathway after a 559-day FDA review.

K032959 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
559d
Days
Class 2
Risk

K032959 is an FDA 510(k) clearance for the CIDEX OPA CONCENTRATE. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on April 4, 2005 after a review of 559 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Advanced Sterilization Products devices

Submission Details

510(k) Number K032959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date April 04, 2005
Days to Decision 559 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
430d slower than avg
Panel avg: 129d · This submission: 559d
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 K032959.
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
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SYSTEM 1.5 STERILE PROCESSING SYSTEM
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RESERT XL HLD HIGH LEVEL DISINFECTANT
K080420 · STERIS Corporation · Sep 2008
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
CIDEX OPA SOLUTION
K001381 · Advanced Sterilization Products · May 2000