Cleared Abbreviated

K030669 - PROVIDENCE MOLDING HELMET

K030669 is an FDA 510(k) clearance for PROVIDENCE MOLDING HELMET, manufactured by Northeast Orthotics and Prothetics, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K030669 · Northeast Orthotics and Prothetics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
137d
Days
Class 2
Risk

K030669 is an FDA 510(k) clearance for the PROVIDENCE MOLDING HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Northeast Orthotics and Prothetics, Inc. (Cranston, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 137 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Northeast Orthotics and Prothetics, Inc. devices

FDA 510(k) Submission Details - K030669

510(k) Number K030669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2003
Decision Date July 18, 2003
Days to Decision 137 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 148d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

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 K030669.
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