Cleared Special

K060618 - CIDEX ACTIVATED DIALDEHYDE SOLUTION

K060618 is an FDA 510(k) clearance for CIDEX ACTIVATED DIALDEHYDE SOLUTION, manufactured by Johnson & Johnson Co.. The device is a Class 2 General Hospital device with product code MED cleared through the Special 510(k) pathway after a 35-day FDA review.

K060618 · Johnson & Johnson Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
35d
Days
Class 2
Risk

K060618 is an FDA 510(k) clearance for the CIDEX ACTIVATED DIALDEHYDE SOLUTION. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Johnson & Johnson Co. (Irvin, US). The FDA issued a Cleared decision on April 12, 2006 after a review of 35 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.

FDA 510(k) Submission Details - K060618

510(k) Number K060618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2006
Decision Date April 12, 2006
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K060618.
OPACIDEN SOLUTION
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STERILOX LIQUID CHEMICAL STERILANT SYSTEM
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K061356 · Advanced Infusion, Inc. · Jul 2006
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
K041984 · Best Sanitizers, Inc. · May 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · Healthpoint, Ltd. · May 2005
CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
K060618 · CIDEX ACTIVATED DIALDEHYDE SOLUTION
Download PDF FDA Summary Johnson & Johnson Co.