Cranial Helmet
510(k) K041215
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041215 | Date9 Sep 2004 | StatusActive |
Official records
- FDA 510(k) database K041215
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- Withdrawn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, 18 Sep 2026
The Cranial Helmet is a cranial orthosis, classified as a Class II medical device under 21 CFR 882.5970. It is designed to provide external support and compression to the skull, typically used in the management of craniosynostosis or other conditions requiring cranial remodeling.
This device is supplied as a reusable, non-sterile orthotic system intended for clinical use under medical supervision. It is regulated under the FDA’s 510(k) clearance (K041215) and falls under the product code MVA, with multiple registration numbers (e.g., 2032381, 3003603920) for tracking. Storage and handling follow manufacturer guidelines to ensure proper fit and function.
From the manufacturer
AUSTIN, Texas, [September 15, 2026] — Ottobock announced today that it has resolved its IP litigation with Cranial Technologies through a settlement agreement on mutually acceptable, confidential terms. Ottobock removed the MyCRO Band cranial helmet product from its U.S. portfolio.