Cleared Traditional

ACU-SIZER(TM) (K941011) - FDA 510(k) Clearance

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

K941011 · Applied Medical Resources · Gastroenterology & Urology device
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Jun 1994
Decision
102d
Days
Class 2
Risk

K941011 is an FDA 510(k) clearance for the ACU-SIZER(TM). Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 102 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 Applied Medical Resources devices

Submission Details

510(k) Number K941011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date June 13, 1994
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYB Catheter, Ureteral, Gastro-urology
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 - EYB Catheter, Ureteral, Gastro-urology

All 13
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K941011.
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc. · Nov 2003
AQ HYDROPHILIC UROLOGICAL CATHETERS
K962004 · Cook Urological, Inc. · Jun 1996
BARD FLEXIBLE TIP URETERAL CATHETER
K950300 · C.R. Bard, Inc. · Apr 1995
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
K933020 · Boston Scientific Corp · Jan 1994
URETERAL CATHETER
K923729 · Cook Urological, Inc. · Dec 1993