Identifiers
- 510(k) Number
- K021918 FDA 510(k)
- FDA Product Code
- OAN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5970 FDA 510(k)
- Regulation Number
- 882.5970 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Clarren Helmet is a patient-specific cranial orthosis designed to apply passive pressure to the infant cranium. Classified as an Orthosis, Cranial, Laser Scan, it is intended for use in infants aged 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head shapes. This device aims to improve cranial symmetry and shape through targeted pressure application.
The Clarren Helmet 703.05A is supplied as a custom-fitted device, manufactured using laser scanning technology to ensure precise alignment with the infant’s cranial structure. It is intended for single-use per patient and requires professional fitting by a healthcare provider. The device is regulated under FDA 510(k) clearance (K021918) and falls under Device Class II (OAN product code). No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the Clarren Helmet 703.05A used for?
The Clarren Helmet 703.05A is a custom-fitted cranial orthosis designed to apply passive pressure to an infant’s skull. It targets moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head shapes in infants aged 3 to 18 months. The device aims to correct cranial asymmetry and improve head shape through precise, targeted pressure.
How is the Clarren Helmet 703.05A supplied and fitted?
The Clarren Helmet 703.05A is supplied as a fully custom-fitted device, manufactured using laser scanning technology to match the infant’s unique cranial structure. Professional fitting by a healthcare provider is required to ensure proper alignment and effectiveness. It is not a one-size-fits-all solution.
Is the Clarren Helmet 703.05A single-use or reusable?
The Clarren Helmet 703.05A is intended for single-use per patient. Since it is patient-specific and designed to conform precisely to an infant’s cranial shape, reuse would compromise its efficacy and safety. Each helmet is tailored to an individual’s needs.
Does the Clarren Helmet 703.05A require any special storage or handling?
The Clarren Helmet 703.05A should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is a single-use, patient-specific device, it should not be reused or shared. Proper packaging should be maintained until ready for professional fitting.
What regulatory approval does the Clarren Helmet 703.05A hold?
The Clarren Helmet 703.05A is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K021918. It is classified as a Class II medical device under the OAN (Orthoses, Cranial) product code and is substantially equivalent to a predicate device. This approval ensures it meets FDA safety and performance standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ORTHOMERICA PRODUCTS, INC. 703.05A Clarren Helmet, Home - Orthomerica Products, Inc., Clarren Helmet - BEUDAMED, PDF FL 510(k) SUMM - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021918 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthomerica Products, Inc.
Sources (1)
- FDA 510(k) K021918 24 fields · synced Oct 1, 2026