Cleared Traditional

DADC '500' DRIVING CONTROL (K884899) - FDA 510(k) Clearance

K884899 · Driving Aids Development Corp. · Physical Medicine device
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Feb 1989
Decision
74d
Days
-
Risk

K884899 is an FDA 510(k) clearance for the DADC '500' DRIVING CONTROL.

Submitted by Driving Aids Development Corp. (Vienna, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. 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 Driving Aids Development Corp. devices

Submission Details

510(k) Number K884899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date February 10, 1989
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPQ
Device Class -