Cleared Traditional

K042110 - BEAMCATH

K042110 is an FDA 510(k) clearance for BEAMCATH, manufactured by Beampoint AB. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K042110 · Beampoint AB · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
204d
Days
Class 2
Risk

K042110 is an FDA 510(k) clearance for the BEAMCATH. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Beampoint AB (Minneapolis,, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 204 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beampoint AB devices

FDA 510(k) Submission Details - K042110

510(k) Number K042110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2004
Decision Date February 25, 2005
Days to Decision 204 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 130d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 64
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K042110.
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