Cleared Traditional

K011433 - BALLERT CRANIAL MOLDING HELMET

K011433 is an FDA 510(k) clearance for BALLERT CRANIAL MOLDING HELMET, manufactured by Gema, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K011433 · Gema, Inc. · Neurology device
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Jun 2001
Decision
33d
Days
Class 2
Risk

K011433 is an FDA 510(k) clearance for the BALLERT CRANIAL MOLDING HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Gema, Inc. (Chicago, US). The FDA issued a Cleared decision on June 12, 2001 after a review of 33 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 - K011433

510(k) Number K011433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date June 12, 2001
Days to Decision 33 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 149d · This submission: 33d
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 K011433.
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
CLARREN HELMET
K003035 · Children'S Hospital & Medical Center · Jun 2001
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K003630 · Danmar Products, Inc. · May 2001
CRANIAL MOLDING ORTHOSIS
K010273 · Orthotic Solutions, Inc. · Apr 2001
K011433 · BALLERT CRANIAL MOLDING HELMET
Download PDF Gema, Inc.