510(k) · Cleared
ClearedSTARband 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthomerica Products, Inc. · OAN Orthosis, Cranial, Laser Scan
Cleared on Mar 15, 2024 as substantially equivalent to K223238 (Orthomerica Products, Inc., 2023) after a 28-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Mar 15, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001167 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 5 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 4 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 3 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 2 generations backK211376 STARbandOrthomerica Products, Inc. · 2021
- 1 generation backK223238 STARband 3DOrthomerica Products, Inc. · 2023
- This deviceK240466 STARband 3DOrthomerica Products, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −5 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −4 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −3 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −2 | K211376 | STARband | Orthomerica Products, Inc. | 2021 | — |
| −1 | K223238 | STARband 3D | Orthomerica Products, Inc. | 2023 | — |
| 0 (this device) | K240466 | STARband 3D | Orthomerica Products, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K223238 | STARband 3DSummary page 5…Classification Name: Cranial Orthosis VI. Legally Marketed Predicate Device and Reference Device ▪ Predicate Device: STARband® 3D™ Cranial Orthosis – K223238 ▪ Reference Device: STARband® Cranial Orthosis – K211376 IV. Device Description/Modification Summary The STARband… | 2023 |
| † | K211376 | STARband | 2021 |
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 24 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 STARband® 3D™ s intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant’s cranium to improve cranial symmetry and/or shape.
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/K240466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240466: STARband 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240466
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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