Cleared Traditional

NOPROFILE OLBERT CATHETER SYSTEM (K945061) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945061 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
146d
Days
Class 2
Risk

K945061 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on March 9, 1995 after a review of 146 days - within the typical 510(k) review window.

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 Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K945061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date March 09, 1995
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K945061.
URETERAL ACCESS SHEATH SET (UASS)
K022135 · Boston Scientific Corp · Sep 2002
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp · Jul 2001
IMAGER TORQUE CATHETER
K965229 · Boston Scientific Corp · Mar 1997
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990