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.

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
26d faster than avg
Panel avg: 116d · 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.

Regulatory Peers - KTC Bath, Sitz, Nonpowered

Devices cleared under the same product code (KTC) and FDA review panel - the closest regulatory comparables to K851309.
THE SPRITZ BATH
K912179 · The Spritz Co. · Aug 1991
SIT-N-BATHE SITZ BATH
K890085 · Drummond Industries, Inc. · Feb 1989
SITZ BATH
K862600 · W. C. Green, D.D.S. · Jul 1986
MAC LEE SITZ BATH
K841711 · Mac Lee Medical Products · May 1984
SITZ BATH, SINGLE PATIENT USE #8100
K831762 · Lsl Industries, Inc. · Jun 1983
PERSONAL SITZ BATH KIT
K800958 · The Healthcare Group Laboratories, Inc. · May 1980
K851309 · ABCO PLASTIC UTENSILS
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