Cleared Traditional

K121171 - CUROS TIP

K121171 is an FDA 510(k) clearance for CUROS TIP, manufactured by Ivera Medical, Inc.. The device is a Class 2 General Hospital device with product code QBP cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K121171 · Ivera Medical, Inc. · General Hospital
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Nov 2012
Decision
223d
Days
Class 2
Risk

K121171 is an FDA 510(k) clearance for the CUROS TIP. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Ivera Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 26, 2012 after a review of 223 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 Ivera Medical, Inc. devices

FDA 510(k) Submission Details - K121171

510(k) Number K121171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2012
Decision Date November 26, 2012
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
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.