Not Cleared Post-NSE

DEN980001 - DYNAMIC ORTHOTIC CRANIOPLASTY BAND (FDA 510(k) Clearance)

Also includes:
DOC BAND

Class II Neurology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN980001 · Cranial Technologies, Inc. · Neurology device
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May 1998
Decision
59d
Days
Class 2
Risk

DEN980001 is an FDA 510(k) submission (not cleared) for the DYNAMIC ORTHOTIC CRANIOPLASTY BAND. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Cranial Technologies, Inc. (Phoenix, US). The FDA issued a Not Cleared (DENG) decision on May 29, 1998 after a review of 59 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Cranial Technologies, Inc. devices

Submission Details

510(k) Number DEN980001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 31, 1998
Decision Date May 29, 1998
Days to Decision 59 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 148d · This submission: 59d
Pathway characteristics

Device Classification

Product Code MVA Orthosis, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MVA Orthosis, Cranial

All 42
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