# DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band

- Pathway: De Novo (Post-NSE)
- Applicant: Cranial Technologies, Inc.
- Decided: May 29, 1998 after 59 days
- Product code: MVA (Orthosis, Cranial)
- 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
No predicates in its family tree.
33 later devices descend from it; 9 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K014012: Doc Band (2002), 21 descendants of its own
- K072566: Hanger Cranial Band (2008), 20 descendants of its own
- K111609: Boston Band (2011), 16 descendants of its own
- K124023: Starband (2013), 15 descendants of its own
- K133250: Starlight (2014), 14 descendants of its own

Source page: https://510kreport.com/device/DEN980001
Methodology: https://510kreport.com/methodology