Cleared Traditional

K864592 - JUDD URETHAL CATHETER CONTAINER

K864592 is an FDA 510(k) clearance for JUDD URETHAL CATHETER CONTAINER, manufactured by Phil Judd, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K864592 · Phil Judd, Inc. · Gastroenterology & Urology device
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Jun 1987
Decision
215d
Days
Class 2
Risk

K864592 is an FDA 510(k) clearance for the JUDD URETHAL CATHETER CONTAINER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Phil Judd, Inc. (Portland, US). The FDA issued a Cleared decision on June 24, 1987 after a review of 215 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 Phil Judd, Inc. devices

FDA 510(k) Submission Details - K864592

510(k) Number K864592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date June 24, 1987
Days to Decision 215 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 130d · This submission: 215d
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 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K864592.
FOLEY CATHETER TEMPERATURE SENSOR
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ANTIMICROBIAL FOLEY CATHETER
K871429 · American Pharmaseal Div. Ahsc · Aug 1987
KADIR HI-TORQUE GUIDE WIRE
K871297 · Argon Medical Corp. · Apr 1987
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
K870977 · American Pharmaseal Div. Ahsc · Apr 1987
VAN-TEC PUMPING SYSTEM
K870557 · Van-Tec, Inc. · Mar 1987