Cleared Special

K050874 - ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER

K050874 is an FDA 510(k) clearance for ASTRA TECH AB LOFRIC PRIMO SINGLE USE U..., 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 29-day FDA review.

K050874 · Astra Tech, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
29d
Days
Class 2
Risk

K050874 is an FDA 510(k) clearance for the ASTRA TECH AB LOFRIC PRIMO 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 May 5, 2005 after a review of 29 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 - K050874

510(k) Number K050874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date May 05, 2005
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
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 K050874.
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
GUARDIANCATHETER-URINARY DRAINAGE CATHETER
K063795 · Marian Medical, Inc. · Mar 2007
PEDIATRIC URINARY CATHETER
K060268 · Clay Kennard · Feb 2006
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241 · Astra Tech, Inc. · Dec 2004
URINARY CATHETERS
K031409 · Promedic, Inc. · Jun 2003
VITALCARE URETHRAL CATHETER
K021938 · Vitalcare, Inc. · Apr 2003
K050874 · ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
Download PDF FDA Summary Astra Tech, Inc.