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 Oct 31, 2008 as substantially equivalent to K081994 (Orthomerica Products, Inc., 2008) after a 29-day review. Its family tree reaches back 3 generations to 2000. 16 later devices descend from it.
- Decided
- Oct 31, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001167 (2000). 16 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 2 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 1 generation backK081994 StarlightOrthomerica Products, Inc. · 2008
- This deviceK082945 StarlightOrthomerica Products, Inc. · 2008
- Descendant · cites it directly · 15 of its ownK090587 StarlightOrthomerica Products, Inc. · 2009
- Descendant · 2 generations on · 14 of its ownK133250 StarlightOrthomerica Products, Inc. · 2014
- Descendant · 3 generations on · 13 of its ownK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- Descendant · 4 generations on · 10 of its ownK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- Descendant · 5 generations on · 9 of its ownK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K090587StarlightOrthomerica Products, Inc. · 2009 · cites it directly15descendants
- K133250StarlightOrthomerica Products, Inc. · 2014 · 2 generations on14descendants
- K140353Starband and StarlightOrthomerica Products, Inc. · 2014 · 3 generations on13descendants
- K141842Starband, StarlightOrthomerica Products, Inc. · 2014 · 4 generations on10descendants
- K151147STARband, STARlightOrthomerica Products, Inc. · 2015 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −2 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −1 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| 0 (this device) | K082945 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| +1 | K090587 | Starlight | Orthomerica Products, Inc. | 2009 | — |
| +2 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| +3 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| +4 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| +5 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K081994 | StarlightSummary page 1…cation: Class II (special controls); OAN; MVA; 21 CFR 882.5970 = Classification Name: Cranial Orthosis • Predicate Device: STARlight, Cranial Orthosis, K081994 III. Manufacturing Site: 6333 North Orange Blossom Trail, Orlando, FL 32810, Telephone: (407) 290-6592, Facsimile: (40… | 2008 |
| † | K021207 | Starlight | 2002 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090587 | Starlight | 2009 | 15 |
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 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090587 (Orthomerica Products, Inc., 2009) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K081994.
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 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 still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082945 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082945: Starlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082945
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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