Cleared Traditional

K020448 - STATIC CRANIOPLASTY ORTHOSIS

K020448 is an FDA 510(k) clearance for STATIC CRANIOPLASTY ORTHOSIS, manufactured by Eastern Cranial Affiliates. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K020448 · Eastern Cranial Affiliates · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
60d
Days
Class 2
Risk

K020448 is an FDA 510(k) clearance for the STATIC CRANIOPLASTY ORTHOSIS. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Eastern Cranial Affiliates (Arlington, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 60 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.

FDA 510(k) Submission Details - K020448

510(k) Number K020448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date April 12, 2002
Days to Decision 60 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
89d faster than avg
Panel avg: 149d · This submission: 60d
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 K020448.
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
O&P CRANICAL MOLDING HELMET
K021221 · Orthotic & Prosthetic Lab, Inc. · Jul 2002
ORTHOSIS HELMET MOLDING
K013700 · Precision Prosthetics & Orthotics, Inc. · Feb 2002
BECKER BAND CRANIAL REMOLDING ORTHOSIS
K013719 · Becker Orthopedic Appliance Co. · Feb 2002
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
K012804 · Scott E Allen CP · Jan 2002
K020448 · STATIC CRANIOPLASTY ORTHOSIS
Download PDF FDA Summary Eastern Cranial Affil…