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 Jan 16, 2014 as substantially equivalent to K090587 (Orthomerica Products, Inc., 2009) and 1 other predicate after an 86-day review. Its family tree reaches back 6 generations to 2000. 14 later devices descend from it.
- Decided
- Jan 16, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001167 (2000). 14 ancestors in all, the oldest DEN980001 (1998). 14 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 5 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 4 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 3 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 2 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 1 generation backK124023 StarbandOrthomerica Products, Inc. · 2013
- This deviceK133250 StarlightOrthomerica Products, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- Descendant · 3 generations on · 9 of its ownK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- Descendant · 5 generations on · 4 of its ownK161138 St. Louis BandOrthomerica Products, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K140353Starband and StarlightOrthomerica Products, Inc. · 2014 · cites it directly13descendants
- K141842Starband, StarlightOrthomerica Products, Inc. · 2014 · 2 generations on10descendants
- K151147STARband, STARlightOrthomerica Products, Inc. · 2015 · 3 generations on9descendants
- K151979STARband, STARlightOrthomerica Products, Inc. · 2015 · 4 generations on8descendants
- K161138St. Louis BandOrthomerica Products, Inc. · 2016 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −5 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −4 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −3 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −2 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −1 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| 0 (this device) | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| +1 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| +2 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| +3 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| +4 | K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| +5 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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 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? (2)
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 |
|---|---|---|---|
| * | K090587 | StarlightSummary page 2…the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The STARlight product family as it was released in K090587 are essentially still the same devices. The STARlight Side Opening design and the STARlight Ri-Valve design are made of a plastic… | 2009 |
| * | K124023 | StarbandSummary page 3…ly to positional deformities and post-operative patients. VI. Predicate Devices " STARlight, Cranial Orthosis, K090587 " STARband. Cranial Orthosis. K 124023 7-10… | 2013 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140353 | Starband and Starlight | 2014 | 13 |
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 14 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K140353 (Orthomerica Products, Inc., 2014) has gone furthest, with 13 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. 2014, 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 3 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 3 to 18 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/K133250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133250: Starlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133250
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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