Cleared Traditional

K851328 - KINETIC AUTO TECHNIC K.A.T. TABLE (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851328 · Buckman Co., Inc. · Physical Medicine device
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Jul 1985
Decision
104d
Days
Class 2
Risk

K851328 is an FDA 510(k) clearance for the KINETIC AUTO TECHNIC K.A.T. TABLE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on July 17, 1985 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K851328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date July 17, 1985
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K851328.
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N7-S
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