Cleared Traditional

K003630 - DANMAR PRODUCTS MICHIGAN CRANIAL HELMET

K003630 is an FDA 510(k) clearance for DANMAR PRODUCTS MICHIGAN CRANIAL HELMET, 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 186-day FDA review.

K003630 · Danmar Products, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
186d
Days
Class 2
Risk

K003630 is an FDA 510(k) clearance for the DANMAR PRODUCTS MICHIGAN CRANIAL HELMET. 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 May 29, 2001 after a review of 186 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K003630

510(k) Number K003630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2000
Decision Date May 29, 2001
Days to Decision 186 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
37d slower than avg
Panel avg: 149d · This submission: 186d
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 K003630.
RHS HELMET
K012007 · Restorative Health Svs, Inc. · Sep 2001
BALLERT CRANIAL MOLDING HELMET
K011433 · Gema, Inc. · Jun 2001
CLARREN HELMET
K003035 · Children'S Hospital & Medical Center · Jun 2001
CRANIAL MOLDING ORTHOSIS
K010273 · Orthotic Solutions, Inc. · Apr 2001
HANGER CRANIAL BAND
K001669 · Hanger Orthopedic Group, Inc. · Dec 2000
CRANIOCAP
K000861 · Gillette Children'S Specialty Healthcare · Oct 2000
K003630 · DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
Download PDF FDA Summary Danmar Products, Inc.