Cleared Traditional

K951260 - URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT

K951260 is an FDA 510(k) clearance for URINARY INTERMITTENT CATHETERS W/O HYDR..., manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K951260 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
190d
Days
Class 2
Risk

K951260 is an FDA 510(k) clearance for the URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 190 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 Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K951260

510(k) Number K951260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date September 27, 1995
Days to Decision 190 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
59d slower than avg
Panel avg: 131d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K951260.
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NOPROFILE OLBERT CATHETER SYSTEM
K945061 · Meadox Surgimed, Inc. · Mar 1995
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195 · Cook Urological, Inc. · Dec 1993