Cleared Abbreviated

K110826 - CUROS PORT PROTECTOR

K110826 is an FDA 510(k) clearance for CUROS PORT PROTECTOR, manufactured by Ivera Medical. The device is a Class 2 General Hospital device with product code QBP cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K110826 · Ivera Medical · General Hospital
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Jun 2011
Decision
91d
Days
Class 2
Risk

K110826 is an FDA 510(k) clearance for the CUROS PORT PROTECTOR. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Ivera Medical (Carlsbad, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ivera Medical devices

FDA 510(k) Submission Details - K110826

510(k) Number K110826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2011
Decision Date June 23, 2011
Days to Decision 91 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

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.