Cleared Traditional

K142806 - DualCap

K142806 is an FDA 510(k) clearance for DualCap, 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 235-day FDA review.

K142806 · Catheter Connections, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K142806

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 129d · This submission: 235d
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.

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 K142806.
Curos Jet Disinfecting Cap
K200299 · 3M Company · Oct 2020
CapKlenZ
K192382 · Star Mountain Medical, Inc. · Apr 2020
SwabTip Male Disinfectant Cap
K190918 · Icu Medical · Mar 2020
CUROS RED PORT PROTECTOR
K140657 · Ivera Medical, Inc. · Dec 2014
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
K142399 · Catheter Connections, Inc. · Nov 2014
SWABCAP AND SWABFLUSH
K130975 · Excelsior Medical Corp. · Dec 2013
K142806 · DualCap
Download PDF FDA Summary Catheter Connections,…