Cleared Traditional

K142806 - DualCap (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142806 · Catheter Connections, Inc. · General Hospital
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May 2015
Decision
235d
Days
Class 2
Risk

K142806 is an FDA 510(k) clearance for the DualCap. 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 May 22, 2015 after a review of 235 days - an extended review cycle.

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

Submission Details

510(k) Number K142806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2014
Decision Date May 22, 2015
Days to Decision 235 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
107d slower than avg
Panel avg: 128d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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