Cleared Traditional

K041215 - CRANIAL HELMET

K041215 is an FDA 510(k) clearance for CRANIAL HELMET, manufactured by Otto Bock Healthcare LP. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K041215 · Otto Bock Healthcare LP · Neurology device
Download Printable Device Report (PDF)
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Sep 2004
Decision
122d
Days
Class 2
Risk

K041215 is an FDA 510(k) clearance for the CRANIAL HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on September 9, 2004 after a review of 122 days - within the typical 510(k) review window.

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 Otto Bock Healthcare LP devices

FDA 510(k) Submission Details - K041215

510(k) Number K041215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date September 09, 2004
Days to Decision 122 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
27d faster than avg
Panel avg: 149d · This submission: 122d
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 41
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K041215.
CRANIAL SOLUTION ORTHOSIS
K063133 · Cranial Solutions · Jul 2007
O&P BIVALVE CRANIAL MOLDING HELMET
K063395 · Orthotic & Prosthetic Lab, Inc. · Dec 2006
DOC BAND-POSTOP
K042385 · Cranial Technologies, Inc. · Dec 2004
COPC BAND
K021594 · Center For Orthotic and Prosthetic Care,Llc · Nov 2003
DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
K013452 · Danmar Products, Inc. · Oct 2003
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
K023572 · Rehabilitation Institute,Loma Linda University Med · Jan 2003