Cleared Traditional

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS (K013452) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013452 · Danmar Products, Inc. · Neurology device
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Oct 2003
Decision
743d
Days
Class 2
Risk

K013452 is an FDA 510(k) clearance for the DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Danmar Products, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 743 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Danmar Products, Inc. devices

Submission Details

510(k) Number K013452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2001
Decision Date October 31, 2003
Days to Decision 743 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
595d slower than avg
Panel avg: 148d · This submission: 743d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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