Cleared Special

K112985 - CATHETER CONNECTIONS' DUALCAP DUO (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K112985 · Catheter Connections, Inc. · General Hospital
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Nov 2011
Decision
34d
Days
Class 2
Risk

K112985 is an FDA 510(k) clearance for the CATHETER CONNECTIONS' DUALCAP DUO. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Catheter Connections, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 9, 2011 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Catheter Connections, Inc. devices

Submission Details

510(k) Number K112985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date November 09, 2011
Days to Decision 34 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 128d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QBP Cap, Device Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time
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 - QBP Cap, Device Disinfectant

All 21
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