Cleared Special

K043241 - LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

K043241 is an FDA 510(k) clearance for LOFRIC HYDRO-KIT II SINGLE USE URINARY ..., manufactured by Astra Tech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Special 510(k) pathway after a 30-day FDA review.

K043241 · Astra Tech, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
30d
Days
Class 2
Risk

K043241 is an FDA 510(k) clearance for the LOFRIC HYDRO-KIT II 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 December 23, 2004 after a review of 30 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.

FDA 510(k) Submission Details - K043241

510(k) Number K043241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date December 23, 2004
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GBM Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K043241.
GUARDIANCATHETER-URINARY DRAINAGE CATHETER
K063795 · Marian Medical, Inc. · Mar 2007
PEDIATRIC URINARY CATHETER
K060268 · Clay Kennard · Feb 2006
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
K050874 · Astra Tech, Inc. · May 2005
URINARY CATHETERS
K031409 · Promedic, Inc. · Jun 2003
VITALCARE URETHRAL CATHETER
K021938 · Vitalcare, Inc. · Apr 2003
SPEEDICATH
K023254 · Coloplast Corp. · Jan 2003
K043241 · LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
Download PDF FDA Summary Astra Tech, Inc.