510(k) · Cleared
ClearedDoc Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cranial Technologies, Inc. · OAN Orthosis, Cranial, Laser Scan
Cleared on Jan 28, 2002 as substantially equivalent to DEN980001 (Cranial Technologies, Inc., 1998) and 1 other predicate after a 54-day review. Its family tree reaches back 1 generation to 1998. 21 later devices descend from it.
- Decided
- Jan 28, 2002
- Review
- 54 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN980001 (1998). 2 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
- This deviceK014012 Doc BandCranial Technologies, Inc. · 2002
- Descendant · cites it directly · 20 of its ownK072566 Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008
- Descendant · 2 generations on · 16 of its ownK111609 Boston BandBoston Brace Intl., Inc. · 2011
- Descendant · 3 generations on · 15 of its ownK124023 StarbandOrthomerica Products, Inc. · 2013
- Descendant · 4 generations on · 14 of its ownK133250 StarlightOrthomerica Products, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K072566Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008 · cites it directly20descendants
- K111609Boston BandBoston Brace Intl., Inc. · 2011 · 2 generations on16descendants
- K124023StarbandOrthomerica Products, Inc. · 2013 · 3 generations on15descendants
- K133250StarlightOrthomerica Products, Inc. · 2014 · 4 generations on14descendants
- K140353Starband and StarlightOrthomerica Products, Inc. · 2014 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band | Cranial Technologies, Inc. | 1998 | — |
| 0 (this device) | K014012 | Doc Band | Cranial Technologies, Inc. | 2002 | — |
| +1 | K072566 | Hanger Cranial Band | Hanger Prosthetics & Orthotics, Inc. | 2008 | — |
| +2 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| +3 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| +4 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| +1 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAN? 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 OAN device
- #1 K244056 DOC Band 3Dscore 9.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band Our OCR of the scanned summary read 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. | 1998 |
| * | K011350 | Starband Cranial OrthosisSummary page 2…. X. Substantial Equivalence; The DOC Band' is substantially equivalent and virtually identical to the original DOC Band described in K964992, to later products such as K011350 cleared by Orthomerica Products and to other products cleared as substantially equivalent to this pioneering predicate device. T… | 2001 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OAN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAN
63in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAN
No recall names OAN since 2007.
Adverse event reports per year · OAN
1in 2020
MAUDE reports naming product code OAN, 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 | 1 | — | 0 | 0 |
| 2008 | 5 | 63 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 63 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended for medical purposes to apply pressure to prominent regions of
an infant's cranium to improve cranial symmetry or shape. To treat infants from three to
eighteen months of age with moderate to severe non-synostotic positional plagiocephaly,
including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014012: Doc Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026