# K244056: DOC Band 3D

- Pathway: 510(k) (Traditional)
- Applicant: Cranial Technologies, Inc.
- Decided: Mar 17, 2025 after 76 days
- Product code: OAN (Orthosis, Cranial, Laser Scan)
- Device class: 2
- Regulation: 21 CFR 882.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN980001 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band, Cranial Technologies, Inc. (1998). Our reading of the summary gave K964992, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980001, Dynamic Orthotic Cranioplasty Band; Doc Band (Cranial Technologies, Inc.), granted May 29, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K042385: Doc Band-Postop, Cranial Technologies, Inc. (2004) Summary page 5.

## Cited in the summary but kept off the family tree
- K141012: Hydrocleanse Wound Care Solution, Oculus Innovative Sciences (2014). Our reading of the summary gave K141012, FDA’s number for Hydrocleanse Wound Care Solution (Oculus Innovative Sciences). Its FDA name has none of the distinctive words the summary uses for the device it names, “DOC Band”. Kept off the family tree. Summary page 5.

## Indications for use
The DOC Band is indicated for use on infants from three to eighteen months of age with moderate to severe non-synostotic cranial deformation, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof. The DOC Band 3D is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic/dolicocephalic- shaped heads, or a combination thereof.

Source page: https://510kreport.com/device/K244056
Methodology: https://510kreport.com/methodology