Cleared Traditional

K051316 - X-FORCE NEPHROSTOMY BALLOON DILATION CA...

K051316 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
59d
Days
-
Risk

K051316 is an FDA 510(k) clearance for the X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on July 18, 2005 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K051316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2005
Decision Date July 18, 2005
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 45
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K051316.
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K981344 · Uresil Corp. · Sep 1998