Cleared Traditional

K873287 - IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)

K873287 is an FDA 510(k) clearance for IRRIGATION TRAY (W/120CC OF STERILE NOR..., manufactured by Todd Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K873287 · Todd Medical, Inc. · Gastroenterology & Urology device
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Nov 1987
Decision
88d
Days
Class 2
Risk

K873287 is an FDA 510(k) clearance for the IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE). Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Todd Medical, Inc. (Brown Deer, US). The FDA issued a Cleared decision on November 13, 1987 after a review of 88 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 Todd Medical, Inc. devices

FDA 510(k) Submission Details - K873287

510(k) Number K873287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received August 17, 1987
Decision Date November 13, 1987
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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 158
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K873287.
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