Cleared Traditional

K851309 - ABCO PLASTIC UTENSILS

K851309 is an FDA 510(k) clearance for ABCO PLASTIC UTENSILS, manufactured by Abco Dealers, Inc.. The device is a Class 1 Physical Medicine device with product code KTC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K851309

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

KTC Device Classification - Class 1, General Controls

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.