Cleared Traditional

K021221 - O&P CRANICAL MOLDING HELMET

K021221 is an FDA 510(k) clearance for O&P CRANICAL MOLDING HELMET, manufactured by Orthotic & Prosthetic Lab, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K021221 · Orthotic & Prosthetic Lab, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
75d
Days
Class 2
Risk

K021221 is an FDA 510(k) clearance for the O&P CRANICAL MOLDING HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Orthotic & Prosthetic Lab, Inc. (Webster Groves, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthotic & Prosthetic Lab, Inc. devices

FDA 510(k) Submission Details - K021221

510(k) Number K021221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2002
Decision Date July 01, 2002
Days to Decision 75 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
73d faster than avg
Panel avg: 148d · This submission: 75d
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 15
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K021221.
STARBAND AND STARLIGHT
K140353 · Orthomerica Products, Inc. · Jun 2014
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