Cleared Traditional

K142399 - DualCap IV Pole Strips(Disinfectant Cap...

K142399 is an FDA 510(k) clearance for DualCap IV Pole Strips(Disinfectant Cap..., manufactured by Catheter Connections, Inc.. The device is a Class 2 General Hospital device with product code QBP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K142399 · Catheter Connections, Inc. · General Hospital
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Nov 2014
Decision
84d
Days
Class 2
Risk

K142399 is an FDA 510(k) clearance for the DualCap IV Pole Strips(Disinfectant Caps for Male Luers). 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 19, 2014 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Catheter Connections, Inc. devices

FDA 510(k) Submission Details - K142399

510(k) Number K142399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date November 19, 2014
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QBP Device Classification - Class 2, Special Controls

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.