Cleared Traditional

K991487 - CIDEX OPA SOLUTION

K991487 is an FDA 510(k) clearance for CIDEX OPA SOLUTION, 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 163-day FDA review.

K991487 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
163d
Days
Class 2
Risk

K991487 is an FDA 510(k) clearance for the CIDEX OPA SOLUTION. 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 October 8, 1999 after a review of 163 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 Advanced Sterilization Products devices

FDA 510(k) Submission Details - K991487

510(k) Number K991487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date October 08, 1999
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
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 46
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K991487.
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · Medivators, Inc. · Aug 2000
CIDEX OPA SOLUTION
K001381 · Advanced Sterilization Products · May 2000
ENDO-SPOR PLUS / HYPROCIDE
K972708 · Cottrell, Ltd. · Sep 1999
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
K984270 · Roger L. Goodman, D.D.S., P.C. · May 1999
SPOROX II STERILIZING & DISINFECTING SOLUTION
K990703 · Reckitt Benckiser, Inc. · Mar 1999