Clarren Helmet

FDA UDI

Class II (US FDA UDI)

by Orthomerica Products, Inc.

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: 703.05A 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: 703.05A FDA UDI
Primary DI / UDI-DI: B15170305A0 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cranial orthosis

The Clarren Helmet is a custom-made, patient-specific cranial orthosis designed to improve cranial symmetry and shape in infants from 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly. Made of durable materials like plastic and solid foam, it provides passive pressure on prominent regions of the cranium to promote growth and alignment.

Similar devices

Also classified as Cranial orthosis.

Hanger Cranial Band — HANGER NATRIONAL LABORATORIES LLC · Class II
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MyCRO Band — OTTO BOCK HEALTHCARE · Class II
Boston Band — Boston Brace International, Inc. · Class II
Michigan Cranial Reshaping Orthosis — DANMAR PRODUCTS, INC. · Class II
Doc Band® — CRANIAL TECHNOLOGIES, INC. · Class II
MyCRO Band — OTTO BOCK HEALTHCARE · Class II
MyCRO Band — OTTO BOCK HEALTHCARE · Class II

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 3b001322-b7aa-44bd-9dae-41a411263edc 36 fields · synced Jul 4, 2026