510(k) · Cleared
ClearedStarband Cranial Orthosis
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 Jul 3, 2001 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Jul 3, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 7 citing it directly.
- This deviceK011350 Starband Cranial OrthosisOrthomerica Products, Inc. · 2001
- Descendant · cites it directly · 21 of its ownK082950 StarbandOrthomerica Products, Inc. · 2008
- 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 · cites it directly · 18 of its ownK072862 Boston-Band Cranial Remodling OrthosisBoston Brace Intl., Inc. · 2008
- Descendant · 2 generations on · 16 of its ownK111609 Boston BandBoston Brace Intl., Inc. · 2011
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K082950StarbandOrthomerica Products, Inc. · 2008 · cites it directly21descendants
- K014012Doc BandCranial Technologies, Inc. · 2002 · cites it directly21descendants
- K072566Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008 · 2 generations on20descendants
- K072862Boston-Band Cranial Remodling OrthosisBoston Brace Intl., Inc. · 2008 · cites it directly18descendants
- K111609Boston BandBoston Brace Intl., Inc. · 2011 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011350 | Starband Cranial Orthosis | Orthomerica Products, Inc. | 2001 | — |
| +1 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| +1 | K014012 | Doc Band | Cranial Technologies, Inc. | 2002 | — |
| +2 | K072566 | Hanger Cranial Band | Hanger Prosthetics & Orthotics, Inc. | 2008 | — |
| +1 | K072862 | Boston-Band Cranial Remodling Orthosis | Boston Brace Intl., Inc. | 2008 | — |
| +2 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 317 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?
- Of its descendants, K082950 (Orthomerica Products, Inc., 2008) has gone furthest, with 21 descendants of its own.
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 | — |
https://510kreport.com/device/K011350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011350: Starband Cranial Orthosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011350
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026