Cleared Traditional

K851328 - KINETIC AUTO TECHNIC K.A.T. TABLE

K851328 is an FDA 510(k) clearance for KINETIC AUTO TECHNIC K.A.T. TABLE, manufactured by Buckman Co., Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

FDA 510(k) Submission Details - K851328

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
Combination Product No
PCCP Authorized No
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.

JFB Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K851328.
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · Chattanooga Group, Inc. · Apr 1990
HI-LO TABLE, MODEL 820-05
K882917 · Tri W-G, Inc. · Jul 1988
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
K862022 · Lic-Orthion · Jun 1986
AUTOTRACTION TABLE
K844233 · Chattanooga Group, Inc. · Dec 1984
PDB II VIBRATING DRAINAGE BED
K843572 · Invacare Corp. · Nov 1984
MASSAGE TABLE AAT-100
K832464 · R&D Systems, Inc. · Aug 1983