510(k) · Cleared
ClearedDOC Band 3D
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 Mar 17, 2025 as substantially equivalent to DEN980001 (Cranial Technologies, Inc., 1998) and 1 other predicate after a 76-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Mar 17, 2025
- Review
- 76 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to DEN980001 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K240466 STARband 3Dscore 8.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band 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. | 1998 |
| Kept off the family tree | K141012 | FDA’s K141012 is Hydrocleanse Wound Care Solution 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…nd any remaining growth of the cranium is primarily from thickening and hardening of the cranial bones. Predicate Device(s): • DOC Band® (K964992) • DOC Band (K141012) • DOC Band PostOpTM (K042385) Substantial Equivalence: The DOC Band 3D is substantially equivalent to the predicate devices… | 2014 |
| * | K042385 | Doc Band-PostopSummary page 5…ium is primarily from thickening and hardening of the cranial bones. Predicate Device(s): • DOC Band® (K964992) • DOC Band (K141012) • DOC Band PostOpTM (K042385) Substantial Equivalence: The DOC Band 3D is substantially equivalent to the predicate devices. The primary difference is the man… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 27 years and passes through 1 company; a new generation was cleared every 20.2 years on median.
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate DEN980001.
How does its category compare?
All OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244056: DOC Band 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244056
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026