Cleared Traditional

K123751 - LOFRIC SENSE

K123751 is an FDA 510(k) clearance for LOFRIC SENSE, manufactured by Wellspect Healthcare. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K123751 · Wellspect Healthcare · Gastroenterology & Urology device
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Feb 2013
Decision
84d
Days
Class 2
Risk

K123751 is an FDA 510(k) clearance for the LOFRIC SENSE. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Wellspect Healthcare (San Diego, US). The FDA issued a Cleared decision on February 28, 2013 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wellspect Healthcare devices

FDA 510(k) Submission Details - K123751

510(k) Number K123751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2012
Decision Date February 28, 2013
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K123751.
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