Cleared Traditional

K083508 - SWABCAP

K083508 is an FDA 510(k) clearance for SWABCAP, manufactured by Excelsior Medical Corp.. The device is a Class 2 General Hospital device with product code QBP cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K083508 · Excelsior Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
153d
Days
Class 2
Risk

K083508 is an FDA 510(k) clearance for the SWABCAP. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Excelsior Medical Corp. (Dundas, On, CA). The FDA issued a Cleared decision on April 28, 2009 after a review of 153 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 Excelsior Medical Corp. devices

FDA 510(k) Submission Details - K083508

510(k) Number K083508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2008
Decision Date April 28, 2009
Days to Decision 153 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
24d slower than avg
Panel avg: 129d · This submission: 153d
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.