Cleared Traditional

K012920 - MOLDED CRANIAL HELMET

K012920 is an FDA 510(k) clearance for MOLDED CRANIAL HELMET, manufactured by Fairview Orthopedic Laboratory. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012920 · Fairview Orthopedic Laboratory · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
90d
Days
Class 2
Risk

K012920 is an FDA 510(k) clearance for the MOLDED CRANIAL HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Fairview Orthopedic Laboratory (Minneapolis, US). The FDA issued a Cleared decision on November 28, 2001 after a review of 90 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K012920

510(k) Number K012920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date November 28, 2001
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
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 K012920.
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
LERMAN & SON CRANIAL ORTHOSIS HELMET
K012830 · Lerman & Son · Nov 2001
CRANIAL HELMET
K013458 · Children'S Hospital · Oct 2001
RHS HELMET
K012007 · Restorative Health Svs, Inc. · Sep 2001
K012920 · MOLDED CRANIAL HELMET
Download PDF FDA Summary Fairview Orthopedic L…