Cleared Traditional

K812281 - TOUCHLESS HOME-CATH

K812281 is an FDA 510(k) clearance for TOUCHLESS HOME-CATH, manufactured by Diamed Division Ill. Tool Works, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K812281 · Diamed Division Ill. Tool Works, Inc. · Gastroenterology & Urology device
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Oct 1981
Decision
61d
Days
Class 2
Risk

K812281 is an FDA 510(k) clearance for the TOUCHLESS HOME-CATH. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Diamed Division Ill. Tool Works, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 61 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 Diamed Division Ill. Tool Works, Inc. devices

FDA 510(k) Submission Details - K812281

510(k) Number K812281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1981
Decision Date October 13, 1981
Days to Decision 61 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
70d faster than avg
Panel avg: 131d · This submission: 61d
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 160
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K812281.
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