Cleared Traditional

K872294 - COMBINATION NITE DRAINAGE UNIT

K872294 is an FDA 510(k) clearance for COMBINATION NITE DRAINAGE UNIT, manufactured by Arnold Technologies. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K872294 · Arnold Technologies · Gastroenterology & Urology device
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Dec 1987
Decision
196d
Days
Class 1
Risk

K872294 is an FDA 510(k) clearance for the COMBINATION NITE DRAINAGE UNIT. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Arnold Technologies (Leesburg, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 196 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 Arnold Technologies devices

FDA 510(k) Submission Details - K872294

510(k) Number K872294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1987
Decision Date December 29, 1987
Days to Decision 196 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
66d slower than avg
Panel avg: 130d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K872294.
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