Cleared Special

K012374 - MODIFICATION TO: LOFRIC PLUS SINGLE USE...

K012374 is the FDA 510(k) clearance for MODIFICATION TO: LOFRIC PLUS SINGLE USE... by Astra Tech, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Special 510(k) pathway after a 28-day FDA review.

K012374 · Astra Tech, Inc. · Gastroenterology & Urology device
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Aug 2001
Decision
28d
Days
Class 2
Risk

K012374 is an FDA 510(k) clearance for the MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Astra Tech, Inc. (Northborough, US). The FDA issued a Cleared decision on August 23, 2001 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Astra Tech, Inc. devices

Submission Details

510(k) Number K012374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date August 23, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 41
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K012374.
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc. · Aug 2009
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
SPEEDICATH
K023254 · Coloplast Corp. · Jan 2003
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · American Medical Systems, Inc. · Mar 1992
AUTOCATH(TM) SET
K910876 · Cook Urological, Inc. · May 1991