Cleared Traditional

K842625 - CUSTOM NEURO TRAY (FDA 510(k) Clearance)

K842625 · Deroyal Industries, Inc. · Neurology device
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Sep 1984
Decision
76d
Days
-
Risk

K842625 is an FDA 510(k) clearance for the CUSTOM NEURO TRAY.

Submitted by Deroyal Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Deroyal Industries, Inc. devices

Submission Details

510(k) Number K842625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date September 20, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -