Cleared Special

K050874 - ASTRA TECH AB LOFRIC PRIMO SINGLE USE U...

K050874 is the FDA 510(k) clearance for ASTRA TECH AB LOFRIC PRIMO SINGLE USE U... by Astra Tech, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Special 510(k) pathway after a 29-day FDA review.

K050874 · Astra Tech, Inc. · Gastroenterology & Urology device
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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.

View all Astra Tech, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
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
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