Cleared Special

K001381 - CIDEX OPA SOLUTION

K001381 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 Special 510(k) pathway after a 15-day FDA review.

K001381 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
15d
Days
Class 2
Risk

K001381 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 May 17, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Sterilization Products devices

Submission Details

510(k) Number K001381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2000
Decision Date May 17, 2000
Days to Decision 15 days
Submission Type Special
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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 K001381.
CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
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
K991487 · Advanced Sterilization Products · Oct 1999
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
K924334 · Johnson & Johnson Medical, Inc. · Mar 1994