Cleared Traditional

KITS AND TRAYS FOR DIALYSIS USE (K871630) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K871630 · Dove Medical Supplies · Gastroenterology & Urology device
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May 1987
Decision
29d
Days
Class 1
Risk

K871630 is an FDA 510(k) clearance for the KITS AND TRAYS FOR DIALYSIS USE. Classified as Tray, Start/stop (including Contents), Dialysis (product code FKG), Class I - General Controls.

Submitted by Dove Medical Supplies (Vancouver, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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.

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Submission Details

510(k) Number K871630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date May 26, 1987
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FKG Tray, Start/stop (including Contents), Dialysis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5820
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.