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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 149d · 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 42
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K030669.
CRANIAL HELMET
K041215 · Otto Bock Healthcare LP · Sep 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
CRANIAL SYMMETRY SYSTEM
K022273 · Beverly Hills Prosthetics Orthotics, Inc. · Sep 2002
O&P CRANICAL MOLDING HELMET
K021221 · Orthotic & Prosthetic Lab, Inc. · Jul 2002
K030669 · PROVIDENCE MOLDING HELMET
Download PDF FDA Summary Northeast Orthotics a…