Cleared Traditional

DELUXE ELECTRIC COMBINATION TILT TABLE (K924019) - FDA 510(k) Clearance

Class I Physical Medicine device.

K924019 · Midland Mfg. Co. · Physical Medicine device
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Nov 1992
Decision
87d
Days
Class 1
Risk

K924019 is an FDA 510(k) clearance for the DELUXE ELECTRIC COMBINATION TILT TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Midland Mfg. Co. (Great Neck, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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: 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 Midland Mfg. Co. devices

Submission Details

510(k) Number K924019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date November 06, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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.