Cleared Traditional

K130975 - SWABCAP AND SWABFLUSH

K130975 is an FDA 510(k) clearance for SWABCAP AND SWABFLUSH, manufactured by Excelsior Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code QBP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K130975 · Excelsior Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
260d
Days
Class 2
Risk

K130975 is an FDA 510(k) clearance for the SWABCAP AND SWABFLUSH. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Excelsior Medical Corp. (Washington, US). The FDA issued a Cleared decision on December 24, 2013 after a review of 260 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5440 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130975

510(k) Number K130975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2013
Decision Date December 24, 2013
Days to Decision 260 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 115d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01301300 Unknown Interventional

Evaluating Central Line Hub Contamination Using a Novel Capping Device

Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device

600
Patients (est.)
4
Sites
Prevention
Purpose
Open label
Masking
Condition studied Catheter-related Bloodstream Infection Due to Central Venous Catheter
Study design Crossover
Eligibility All sexes · 18 Years+
Sponsor Endeavor Health
Started 2010-04-01 → Primary completion 2011-09-01 → Completed 2011-12-01
Primary outcome
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
Secondary outcome
Central line associated bloodstream infections
View full study on ClinicalTrials.gov

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 K130975.
DualCap
K142806 · Catheter Connections, Inc. · May 2015
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
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
K123967 · Catheter Connections, Inc. · Jan 2013
CATHETER CONNECTIONS DUALCAP SOLO
K123065 · Catheter Connections, Inc. · Dec 2012
CUROS TIP
K121171 · Ivera Medical, Inc. · Nov 2012
K130975 · SWABCAP AND SWABFLUSH
Download PDF FDA Summary Excelsior Medical Cor…