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 Sep 12, 2008 as substantially equivalent to K021207 (Orthomerica Products, Inc., 2002) after a 60-day review. Its family tree reaches back 2 generations to 2000. 24 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001167 (2000). 24 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 1 generation backK021207 StarlightOrthomerica Products, Inc. · 2002
- This deviceK081994 StarlightOrthomerica Products, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK082950 StarbandOrthomerica Products, Inc. · 2008
- Descendant · 2 generations on · 16 of its ownK111609 Boston BandBoston Brace Intl., Inc. · 2011
- Descendant · cites it directly · 16 of its ownK082945 StarlightOrthomerica Products, Inc. · 2008
- Descendant · 2 generations on · 15 of its ownK124023 StarbandOrthomerica Products, Inc. · 2013
- Descendant · 2 generations on · 15 of its ownK090587 StarlightOrthomerica Products, Inc. · 2009
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K082950StarbandOrthomerica Products, Inc. · 2008 · cites it directly21descendants
- K111609Boston BandBoston Brace Intl., Inc. · 2011 · 2 generations on16descendants
- K082945StarlightOrthomerica Products, Inc. · 2008 · cites it directly16descendants
- K124023StarbandOrthomerica Products, Inc. · 2013 · 2 generations on15descendants
- K090587StarlightOrthomerica Products, Inc. · 2009 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −1 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| 0 (this device) | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| +1 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| +2 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| +1 | K082945 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| +2 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| +2 | K090587 | Starlight | Orthomerica Products, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K021207 | StarlightSummary page 1…ssification: Class II (special controls); OAN; 21 CFR 882.5970 * Classification Name: Cranial Orthosis · Predicate Device: STARlight, Cranial Orthosis, K021207 III. Manufacturing Site: 6333 North Orange Blossom Trail, Orlando, FL 32810, Telephone: (407) 290-6592, Facsimile: (40… | 2002 |
What descends from it? (24)
See all 242 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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- 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. 2008, 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 STARlight is intended for medical purposes 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. 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 still 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/K081994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081994: Starlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081994
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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