De Novo · Granted
GrantedDynamic Orthotic Cranioplasty Band; Doc Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cranial Technologies, Inc. · MVA Orthosis, Cranial
Granted on May 29, 1998 as a new device type through De Novo after a 59-day review. 33 later devices descend from it.
- Decided
- May 29, 1998
- Review
- 59 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
33 later devices descend from it, 9 citing it directly.
- This deviceDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
- Descendant · cites it directly · 21 of its ownK014012 Doc BandCranial Technologies, Inc. · 2002
- Descendant · 2 generations on · 20 of its ownK072566 Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008
- Descendant · 3 generations on · 16 of its ownK111609 Boston BandBoston Brace Intl., Inc. · 2011
- Descendant · 4 generations on · 15 of its ownK124023 StarbandOrthomerica Products, Inc. · 2013
- Descendant · 5 generations on · 14 of its ownK133250 StarlightOrthomerica Products, Inc. · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K014012Doc BandCranial Technologies, Inc. · 2002 · cites it directly21descendants
- K072566Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008 · 2 generations on20descendants
- K111609Boston BandBoston Brace Intl., Inc. · 2011 · 3 generations on16descendants
- K124023StarbandOrthomerica Products, Inc. · 2013 · 4 generations on15descendants
- K133250StarlightOrthomerica Products, Inc. · 2014 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band | Cranial Technologies, Inc. | 1998 | — |
| +1 | K014012 | Doc Band | Cranial Technologies, Inc. | 2002 | — |
| +2 | K072566 | Hanger Cranial Band | Hanger Prosthetics & Orthotics, Inc. | 2008 | — |
| +3 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| +4 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| +5 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MVA device
- #1 K230444 Talee, Talee PostOpscore 11.8 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (33)
See all 339 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014012 | Doc Band | 2002 | 21 |
| K013700 | Orthosis Helmet Molding | 2002 | 6 |
| K020448 | Static Cranioplasty Orthosis | 2002 | 2 |
| K042385 | Doc Band-Postop | 2004 | 1 |
| K012804 | Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis | 2002 | 1 |
| K012920 | Molded Cranial Helmet | 2001 | 1 |
| K244056 | DOC Band 3D | 2025 | 0 |
| K021594 | Copc Band | 2003 | 0 |
| K013719 | Becker Band Cranial Remolding Orthosis | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K014012 (Cranial Technologies, Inc., 2002) has gone furthest, with 21 descendants of its own.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MVA
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVA
No recall names MVA since 2007.
Adverse event reports per year · MVA
1in 2022
MAUDE reports naming product code MVA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 3 | 104 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 114 | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 209 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN980001 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN980001
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026