Cleared Traditional

K111247 - CRANIAL REMOLDING ORTHOSIS

K111247 is an FDA 510(k) clearance for CRANIAL REMOLDING ORTHOSIS, manufactured by Orthotic Care Services, Llp. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K111247 · Orthotic Care Services, Llp · Neurology device
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Aug 2011
Decision
104d
Days
Class 2
Risk

K111247 is an FDA 510(k) clearance for the CRANIAL REMOLDING ORTHOSIS. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Orthotic Care Services, Llp (St.Paul, US). The FDA issued a Cleared decision on August 15, 2011 after a review of 104 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.

View all Orthotic Care Services, Llp devices

FDA 510(k) Submission Details - K111247

510(k) Number K111247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2011
Decision Date August 15, 2011
Days to Decision 104 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
44d faster than avg
Panel avg: 148d · This submission: 104d
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 14
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K111247.
KidCap
K180568 · Eastern Cranial Affiliates, LLC · Oct 2018
STARBAND, STARLIGHT
K141842 · Orthomerica Products, Inc. · Oct 2014
STARBAND AND STARLIGHT
K140353 · Orthomerica Products, Inc. · Jun 2014
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