Cleared Traditional

K934072 - CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM

K934072 is an FDA 510(k) clearance for CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM, manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K934072 · Contour Fabricators of Florida, Inc. · Gastroenterology & Urology device
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Sep 1994
Decision
384d
Days
Class 2
Risk

K934072 is an FDA 510(k) clearance for the CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Contour Fabricators of Florida, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 384 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Contour Fabricators of Florida, Inc. devices

FDA 510(k) Submission Details - K934072

510(k) Number K934072 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 20, 1993
Decision Date September 08, 1994
Days to Decision 384 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
254d slower than avg
Panel avg: 130d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

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

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K934072.
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · Orion Life Systems, Inc. · Jan 1995
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · Boston Scientific Corp · Oct 1994
UROLOGICAL GUIDWIRE
K944135 · Applied Medical Resources · Sep 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
URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993