Cleared Traditional

K013452 - DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

K013452 is an FDA 510(k) clearance for DANMAR PRODUCTS CRANIAL ADJUSTIVE PROST..., manufactured by Danmar Products, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 743-day FDA review.

K013452 · Danmar Products, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K013452

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
594d slower than avg
Panel avg: 149d · This submission: 743d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVA Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K013452.
DOC BAND-POSTOP
K042385 · Cranial Technologies, Inc. · Dec 2004
CRANIAL HELMET
K041215 · Otto Bock Healthcare LP · Sep 2004
COPC BAND
K021594 · Center For Orthotic and Prosthetic Care,Llc · Nov 2003
PROVIDENCE MOLDING HELMET
K030669 · Northeast Orthotics and Prothetics, Inc. · Jul 2003
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
K023572 · Rehabilitation Institute,Loma Linda University Med · Jan 2003
CRANIAL SYMMETRY SYSTEM
K022273 · Beverly Hills Prosthetics Orthotics, Inc. · Sep 2002
K013452 · DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
Download PDF FDA Summary Danmar Products, Inc.