510(k) · Cleared
ClearedStarlight
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 9, 2002 as substantially equivalent to K001167 (Orthomerica Products, Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 25 later devices descend from it.
- Decided
- Jul 9, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001167 (2000). 25 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001167 Opi BandOrthomerica Products, Inc. · 2000
- This deviceK021207 StarlightOrthomerica Products, Inc. · 2002
- Descendant · cites it directly · 24 of its ownK081994 StarlightOrthomerica Products, Inc. · 2008
- Descendant · 2 generations on · 21 of its ownK082950 StarbandOrthomerica Products, Inc. · 2008
- Descendant · 3 generations on · 16 of its ownK111609 Boston BandBoston Brace Intl., Inc. · 2011
- Descendant · 2 generations on · 16 of its ownK082945 StarlightOrthomerica Products, Inc. · 2008
- Descendant · 3 generations on · 15 of its ownK124023 StarbandOrthomerica Products, Inc. · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K081994StarlightOrthomerica Products, Inc. · 2008 · cites it directly24descendants
- K082950StarbandOrthomerica Products, Inc. · 2008 · 2 generations on21descendants
- K111609Boston BandBoston Brace Intl., Inc. · 2011 · 3 generations on16descendants
- K082945StarlightOrthomerica Products, Inc. · 2008 · 2 generations on16descendants
- K124023StarbandOrthomerica Products, Inc. · 2013 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| 0 (this device) | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| +1 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| +2 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| +3 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| +2 | K082945 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| +3 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K001167 | Opi BandSummary page 1…mon or Usual Name: Cranial remolding orthosis o ClassificationName: Cranial orthosis o Predkate Device: STARbandTMCranial Remolding Orthosis, K001167, classified under 21 CFR fj882.5970 C. Device Description The STARlight is a cranial remolding orthosis used… | 2000 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081994 | Starlight | 2008 | 24 |
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?
The STARlight is available by prescription only and intended for use in 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.
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/K021207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021207: Starlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021207
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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