Data / Medical devices / United States / Cranial Technologies, Inc.
Cranial Technologies, Inc.: FDA-registered device maker in Chandler, AZ, United States, 4 510(k) clearances
Cranial Technologies, Inc. is registered with the FDA (registration 2030829) in Chandler, AZ, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2030829
- FEI number
- 3000215614
- Address
- 6511 W Frye Rd, Suite 3, Chandler, AZ, United States, 85226
- Owner or operator
- Cranial Technologies, Inc. (10039513)
- Roles
- Manufacturer
- First device listed
- January 18, 2012
- Registered through
- 2026
- Brand names listed
- DOC Band, DOC Band - PostOp, DOC Band 3D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Cranial | MVA | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial, Laser Scan | OAN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2025 | K244056 | DOC Band 3D | OAN | Substantially Equivalent | Cranial Technologies, Inc. | accessdata.fda.gov |
| December 17, 2004 | K042385 | DOC BAND-POSTOP | MVA | Substantially Equivalent | Cranial Technologies, Inc. | accessdata.fda.gov |
| January 28, 2002 | K014012 | DOC BAND | OAN | Substantially Equivalent | Cranial Technologies, Inc. | accessdata.fda.gov |
| May 29, 1998 | DEN980001 | DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND | MVA | Unknown | Cranial Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.