O&P Bivalve Cranial Molding Helmet
by Orthotic & Prosthetic Lab, Inc.
510(k) K063395
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063395 | Date22 Dec 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MVA
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5970
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The O&P Bivalve Cranial Molding Helmet is a cranial orthosis designed to apply gentle, controlled pressure to the skull in infants with positional plagiocephaly or craniosynostosis. Classified as an orthosis, cranial, it is intended to reshape the head by redistributing forces over targeted areas through a custom-fitted, bivalve (two-part) design.
This device is supplied as a reusable, non-sterile medical orthotic system and is regulated under 21 CFR 882.5970. It is fitted directly to the infant’s head under clinical supervision and requires periodic adjustments to maintain proper pressure distribution. The helmet is manufactured by Orthotic & Prosthetic Lab, Inc., and holds an FDA 510(k) clearance (K063395) as substantially equivalent to a predicate device, with no specific MRI safety or sterility requirements stated.
Other devices from Orthotic & Prosthetic Lab, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the O&P Bivalve Cranial Molding Helmet designed to treat, and how does it work?
The O&P Bivalve Cranial Molding Helmet is designed to address positional plagiocephaly or craniosynostosis in infants by reshaping the skull. It applies gentle, controlled pressure through a custom-fitted, two-part (bivalve) design to redistribute forces over targeted areas, promoting gradual head reshaping under clinical supervision.
Is the helmet reusable or single-use, and what are the sterility requirements?
The helmet is supplied as a reusable, non-sterile medical orthotic system. Since it is not intended for sterile procedures and is regulated under 21 CFR 882.5970, no specific sterility requirements are stated in the documentation.
How is the helmet fitted to an infant’s head, and how often does it require adjustments?
The helmet is fitted directly to the infant’s head under clinical supervision. Periodic adjustments are necessary to maintain proper pressure distribution and ensure effective reshaping of the skull.
What regulatory pathway was followed for FDA clearance, and which medical specialty oversees this device?
The O&P Bivalve Cranial Molding Helmet received FDA clearance through a 510(k) submission, specifically a *Traditional* review pathway, and was deemed *Substantially Equivalent* to a predicate device. The device falls under the *Neurology* medical specialty, as indicated by the advisory committee (NE) and regulatory records.
Are there any specific storage instructions or considerations for this helmet?
While the documentation does not explicitly detail storage instructions, as a reusable, non-sterile orthotic device, it should be stored in a clean, dry environment to prevent contamination or damage. Proper cleaning and maintenance per manufacturer guidelines are recommended to ensure longevity and functionality.