Cleared Traditional

K991487 - CIDEX OPA SOLUTION

K991487 is the FDA 510(k) clearance for CIDEX OPA SOLUTION by Advanced Sterilization Products. It is a Class 2 General Hospital device (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

Submission Details

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.

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 K991487.
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
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
K924334 · Johnson & Johnson Medical, Inc. · Mar 1994