Cleared Traditional

K182463 - Silicone Foley Catheter

K182463 is the FDA 510(k) clearance for Silicone Foley Catheter by Biosensors International Pte, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K182463 · Biosensors International Pte, Ltd. · Gastroenterology & Urology device
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Nov 2019
Decision
422d
Days
Class 2
Risk

K182463 is an FDA 510(k) clearance for the Silicone Foley Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Biosensors International Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on November 6, 2019 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Biosensors International Pte, Ltd. devices

Submission Details

510(k) Number K182463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date November 06, 2019
Days to Decision 422 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
292d slower than avg
Panel avg: 130d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 58
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