Cleared Traditional

K925161 - NORTEC STERILE WATER FOR CATHETER BALLO...

K925161 is the FDA 510(k) clearance for NORTEC STERILE WATER FOR CATHETER BALLO... by North American Sterilization & Packaging Co.. It is a Class 2 Gastroenterology & Urology device (product code KNY) cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K925161 · North American Sterilization & Packaging Co. · Gastroenterology & Urology device
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Jul 1993
Decision
281d
Days
Class 2
Risk

K925161 is an FDA 510(k) clearance for the NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 281 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 North American Sterilization & Packaging Co. devices

Submission Details

510(k) Number K925161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date July 21, 1993
Days to Decision 281 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 130d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K925161.
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · Boston Scientific Corp · Oct 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205 · Boston Scientific Corp · Jul 1994
FLEXI-TRAK ANCHORING DEVICE
K932143 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990