Cleared Traditional

K032959 - CIDEX OPA CONCENTRATE

K032959 is an FDA 510(k) clearance for CIDEX OPA CONCENTRATE, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K032959

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.

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 64
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K032959.
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K060618 · Johnson & Johnson Co. · Apr 2006
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
K041984 · Best Sanitizers, Inc. · May 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · Healthpoint, Ltd. · May 2005
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
K033381 · Discus Dental, Inc. · Jan 2004
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K012889 · Pascal Co., Inc. · May 2003
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · Advanced Sterilization Products · Feb 2003
K032959 · CIDEX OPA CONCENTRATE
Download PDF FDA Summary Advanced Sterilizatio…