Cleared Traditional

K863282 - CARE + PLUS CATHETER CARE TRAY

K863282 is the FDA 510(k) clearance for CARE + PLUS CATHETER CARE TRAY by Welmed Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K863282 · Welmed Systems, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
67d
Days
Class 2
Risk

K863282 is an FDA 510(k) clearance for the CARE + PLUS CATHETER CARE TRAY. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Welmed Systems, Inc. (West Swanzey, US). The FDA issued a Cleared decision on October 31, 1986 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Welmed Systems, Inc. devices

Submission Details

510(k) Number K863282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date October 31, 1986
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
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 70
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K863282.
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · Cook Urological, Inc. · Mar 1988
COOK-VPI INTERMITTENT CATHETER
K863082 · Cook Urological, Inc. · Nov 1986
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · Abco Dealers, Inc. · Jul 1984