Cleared Traditional

K851309 - ABCO PLASTIC UTENSILS (FDA 510(k) Clearance)

Class I Physical Medicine device.

K851309 · Abco Dealers, Inc. · Physical Medicine device
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Jul 1985
Decision
90d
Days
Class 1
Risk

K851309 is an FDA 510(k) clearance for the ABCO PLASTIC UTENSILS. Classified as Bath, Sitz, Nonpowered (product code KTC), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5125 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Abco Dealers, Inc. devices

Submission Details

510(k) Number K851309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1985
Decision Date July 01, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTC Bath, Sitz, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5125
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.