510(k) · Cleared
ClearedStarband and Starlight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthomerica Products, Inc. · MVA Orthosis, Cranial
Cleared on Jun 6, 2014 as substantially equivalent to K124023 (Orthomerica Products, Inc., 2013) and 2 other predicates after a 114-day review. Its family tree reaches back 7 generations to 2000. 13 later devices descend from it.
- Decided
- Jun 6, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001167 (2000). 15 ancestors in all, the oldest DEN980001 (1998). 13 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 6 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 5 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 4 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 3 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 2 generations backK124023 StarbandOrthomerica Products, Inc. · 2013
- 1 generation backK133250 StarlightOrthomerica Products, Inc. · 2014
- This deviceK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- Descendant · 4 generations on · 3 of its ownK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K141842Starband, StarlightOrthomerica Products, Inc. · 2014 · cites it directly10descendants
- K151147STARband, STARlightOrthomerica Products, Inc. · 2015 · 2 generations on9descendants
- K151979STARband, STARlightOrthomerica Products, Inc. · 2015 · 3 generations on8descendants
- K161138St. Louis BandOrthomerica Products, Inc. · 2016 · 4 generations on4descendants
- K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −6 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −5 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −4 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −3 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −2 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| −1 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| 0 (this device) | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| +1 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| +2 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| +3 | K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| +4 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| +4 | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
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 | 1 | 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 MVA? 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 MVA device
- #1 K230444 Talee, Talee PostOpscore 11.8 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K124023 | StarbandSummary page 2…ast resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The STARband and STARlight product families as it was released in K1 24023 and K133250 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an… | 2013 |
| * | K133250 | StarlightSummary page 2…e and creates a precise pathway for the head shape to improve in symmetry and proportion. The STARband and STARlight product families as it was released in K1 24023 and K133250 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell… | 2014 |
| * | K014012 | Doc BandSummary page 3…ies and post-operative patients. VI. Predicate Devices * STARband, Cranial Orthosis, K 124023 * STARlight, Cranial Orthosis, K133250 " DoecBand, K014012 VI. Summary of Technological Characteristics The 3dMD Systems proposed in this 510O(k) are additional methods to capture t… | 2002 |
What descends from it? (13)
See all 132 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 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K141842 (Orthomerica Products, Inc., 2014) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K124023.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MVA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MVA
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVA
No recall names MVA since 2007.
Adverse event reports per year · MVA
1in 2022
MAUDE reports naming product code MVA, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 3 | 104 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 114 | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 209 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STARband and STARlight is intended for medical purposes for use an 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140353: Starband and Starlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140353
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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