Cleared Traditional

K140703 - OPA 30 SOLUTION

K140703 is an FDA 510(k) clearance for OPA 30 SOLUTION, manufactured by Ciden Technologies, LLC. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K140703 · Ciden Technologies, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
152d
Days
Class 2
Risk

K140703 is an FDA 510(k) clearance for the OPA 30 SOLUTION. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Ciden Technologies, LLC (Orange, US). The FDA issued a Cleared decision on August 19, 2014 after a review of 152 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 Ciden Technologies, LLC devices

FDA 510(k) Submission Details - K140703

510(k) Number K140703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2014
Decision Date August 19, 2014
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 129d · This submission: 152d
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 31
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K140703.
System 1 endo Liquid Chemical Sterilant Processing System
K173256 · STERIS Corporation · Mar 2018
SYSTEM 1E Liquid Chemical Sterilant Processing System
K170956 · STERIS Corporation · Sep 2017
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · STERIS Corporation · Aug 2016
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K131078 · STERIS Corporation · Jul 2013
RAPICIDE OPA-28
K120306 · Minntech Corp. · Sep 2012
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K113520 · STERIS Corporation · Feb 2012