Cleared Traditional

K883680 - MEDALIST EXAMINATION TABLE

K883680 is the FDA 510(k) clearance for MEDALIST EXAMINATION TABLE by Hamilton Industries, Inc.. It is a Class 1 General Hospital device (product code LGX) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K883680 · Hamilton Industries, Inc. · General Hospital
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Oct 1988
Decision
36d
Days
Class 1
Risk

K883680 is an FDA 510(k) clearance for the MEDALIST EXAMINATION TABLE. Classified as Table, Examination, Medical, Powered (product code LGX), Class I - General Controls.

Submitted by Hamilton Industries, Inc. (Two Rivers, US). The FDA issued a Cleared decision on October 4, 1988 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4960 - the FDA general hospital 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 Hamilton Industries, Inc. devices

Submission Details

510(k) Number K883680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date October 04, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGX Table, Examination, Medical, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - LGX Table, Examination, Medical, Powered

All 7
Devices cleared under the same product code (LGX) and FDA review panel - the closest regulatory comparables to K883680.
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