Cleared Traditional

K003035 - CLARREN HELMET

K003035 is an FDA 510(k) clearance for CLARREN HELMET, manufactured by Children'S Hospital & Medical Center. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K003035 · Children'S Hospital & Medical Center · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
251d
Days
Class 2
Risk

K003035 is an FDA 510(k) clearance for the CLARREN HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Children'S Hospital & Medical Center (Washington, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 251 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.

View all Children'S Hospital & Medical Center devices

FDA 510(k) Submission Details - K003035

510(k) Number K003035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2000
Decision Date June 06, 2001
Days to Decision 251 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
103d slower than avg
Panel avg: 148d · This submission: 251d
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 18
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K003035.
CRANIAL REMOLDING ORTHOSIS
K111247 · Orthotic Care Services, Llp · Aug 2011
AOI CRANIAL HELMET
K103362 · Advanced Orthopro, Inc. · Apr 2011
CRANIAL HELMET
K041215 · Otto Bock Healthcare LP · Sep 2004
OPI BAND
K001167 · Orthomerica Products, Inc. · Jul 2000
DYNAMIC ORTHOTIC CRANIOPLASTY BAND
DEN980001 · Cranial Technologies, Inc. · May 1998