Cleared Traditional

K872121 - K AND D HOME TRACT

K872121 is an FDA 510(k) clearance for K AND D HOME TRACT, manufactured by Joseph A. Kott, M.D.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K872121 · Joseph A. Kott, M.D. · Neurology device
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Aug 1987
Decision
77d
Days
Class 1
Risk

K872121 is an FDA 510(k) clearance for the K AND D HOME TRACT. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Joseph A. Kott, M.D. (Metairie, US). The FDA issued a Cleared decision on August 12, 1987 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Joseph A. Kott, M.D. devices

FDA 510(k) Submission Details - K872121

510(k) Number K872121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date August 12, 1987
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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 - HST Apparatus, Traction, Non-powered

All 19
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K872121.
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ARTHROSCOPIC SHOULDER HOLDER
K870212 · Dyonics, Inc. · Feb 1987
EXTREMITY ELEVATOR
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TUPPER TROLLEY
K870102 · Orthopedic Systems, Inc. · Feb 1987