Cleared Traditional

K142399 - DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (FDA 510(k) Clearance)

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

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

Submission Details

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
44d faster than avg
Panel avg: 128d · This submission: 84d
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
Devices cleared under the same product code (QBP) and FDA review panel - the closest regulatory comparables to K142399.
OTTO™ Disinfecting Cap
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SteriHub™ Disinfecting Device and Protective Cover
K251592 · 1World Vista Medical · Feb 2026
ACTIV™ Cap
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BD PureHub Disinfecting Cap
K193190 · Becton, Dickinson and Company · Nov 2020
Curos Jet Disinfecting Cap
K200299 · 3M Company · Oct 2020
CapKlenZ
K192382 · Star Mountain Medical, Inc. · Apr 2020