Cleared Traditional

K122078 - LOFRIC PRIMO, LOFRIC HYDRO-KIT

K122078 is an FDA 510(k) clearance for LOFRIC PRIMO, manufactured by Astra Tech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K122078 · Astra Tech, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
107d
Days
Class 2
Risk

K122078 is an FDA 510(k) clearance for the LOFRIC PRIMO, LOFRIC HYDRO-KIT. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Astra Tech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 31, 2012 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122078

510(k) Number K122078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date October 31, 2012
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 131d · This submission: 107d
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 85
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K122078.
CLASSIC INTERMITTENT CATHETER
K132619 · Flexicare Medical, Ltd. · Oct 2013
HYDROSIL
K122785 · Rochester Medical Corp. · May 2013
LOFRIC SENSE
K123751 · Wellspect Healthcare · Feb 2013
LOFRIC SINGLE USE URINARY CATHETER
K113424 · Astra Tech AB · Apr 2012
COMFORTGLIDE INTERMITENT CATHETER
K112137 · C.R. Bard, Inc. · Aug 2011
CURE CATHETER
K110653 · Cure Medical, LLC · Aug 2011
K122078 · LOFRIC PRIMO, LOFRIC HYDRO-KIT
Download PDF FDA Summary Astra Tech, Inc.