Identity
- Trade Name
- Clarren Helmet FDA UDI
- Generic Name
- Cranial orthosis FDA UDI
- Device Name
- The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic- shaped heads. The Clarren Helmet is made with an outer polypropylene plastic shell with a Plastizote inner liner and a chinstrap to help hold the helmet in place. FDA UDI
- Model / Reference
- 704.05A FDA UDI
- Description
- The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic- shaped heads. The Clarren Helmet is made with an outer polypropylene plastic shell with a Plastizote inner liner and a chinstrap to help hold the helmet in place. FDA UDI
Identifiers
- Catalog Number
- 704.05A FDA UDI
- Primary DI / UDI-DI
- B15170405A0 FDA UDI
- 510(k) Number
- K021918 FDA UDI
- FDA Product Code
- MVA FDA UDI
- GMDN Term
- Cranial orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cranial orthosis
Clarren Helmet by Orthomerica Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cranial orthosis.
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Cleared under the same submission
K021918 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthomerica Products, Inc.
Sources (1)
- FDA UDI e4414068-1a8b-4973-9a8d-e080bb52e5e4 36 fields · synced May 29, 2026