510(k) · Cleared
ClearedSTARband
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 Aug 17, 2021 as substantially equivalent to K082950 (Orthomerica Products, Inc., 2008) after a 105-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 17, 2021
- Review
- 105 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001167 (2000). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 3 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 2 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 1 generation backK082950 StarbandOrthomerica Products, Inc. · 2008
- This deviceK211376 STARbandOrthomerica Products, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK223238 STARband 3DOrthomerica Products, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK240466 STARband 3DOrthomerica Products, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −3 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −2 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −1 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| 0 (this device) | K211376 | STARband | Orthomerica Products, Inc. | 2021 | — |
| +1 | K223238 | STARband 3D | Orthomerica Products, Inc. | 2023 | — |
| +2 | K240466 | STARband 3D | Orthomerica Products, Inc. | 2024 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K082950 | StarbandSummary page 5…a Velcro strap with chafe and loop. The STARband® Plus cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K082950. The difference with this proposed device is a structural change to a dual side opening design with a living hinge at the top. Th… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223238 | STARband 3D | 2023 | 1 |
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 21 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K223238 (Orthomerica Products, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K082950.
How does its category compare?
All OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 is intended for medical purposes for use on infants from three 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 in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211376: STARband.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211376
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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