Cleared Traditional

K023572 - LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET

K023572 is an FDA 510(k) clearance for LOMA LINDA UNIVERSITY MEDICAL CENTER (L..., manufactured by Rehabilitation Institute,Loma Linda University Med. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K023572 · Rehabilitation Institute,Loma Linda University Med · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
81d
Days
Class 2
Risk

K023572 is an FDA 510(k) clearance for the LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Rehabilitation Institute,Loma Linda University Med (Chicago, US). The FDA issued a Cleared decision on January 13, 2003 after a review of 81 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 Rehabilitation Institute,Loma Linda University Med devices

FDA 510(k) Submission Details - K023572

510(k) Number K023572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2002
Decision Date January 13, 2003
Days to Decision 81 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
67d faster than avg
Panel avg: 148d · This submission: 81d
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 K023572.
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