510(k) · Cleared
ClearedStarband, 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 Oct 6, 2014 as substantially equivalent to K140353 (Orthomerica Products, Inc., 2014) after a 90-day review. Its family tree reaches back 8 generations to 2000. 10 later devices descend from it.
- Decided
- Oct 6, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001167 (2000). 16 ancestors in all, the oldest DEN980001 (1998). 10 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 7 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 6 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 5 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 4 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 3 generations backK124023 StarbandOrthomerica Products, Inc. · 2013
- 2 generations backK133250 StarlightOrthomerica Products, Inc. · 2014
- 1 generation backK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- This deviceK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- Descendant · cites it directly · 9 of its ownK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK220681 Talee, Talee PostOPInvent Medical USA, LLC · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151147STARband, STARlightOrthomerica Products, Inc. · 2015 · cites it directly9descendants
- K151979STARband, STARlightOrthomerica Products, Inc. · 2015 · 2 generations on8descendants
- K161138St. Louis BandOrthomerica Products, Inc. · 2016 · 3 generations on4descendants
- K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018 · 3 generations on3descendants
- K220681Talee, Talee PostOPInvent Medical USA, LLC · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −7 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −6 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −5 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −4 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −3 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| −2 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| −1 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| 0 (this device) | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| +1 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| +2 | K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| +3 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| +3 | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
| +3 | K220681 | Talee, Talee PostOP | Invent Medical USA, LLC | 2022 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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? (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 |
|---|---|---|---|
| * | K140353 | Starband and StarlightSummary page 5…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 K140353 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell… | 2014 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151147 | STARband, STARlight | 2015 | 9 |
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 16 ancestors has a recall.
- Of its descendants, K151147 (Orthomerica Products, Inc., 2015) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K140353.
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 are 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. These devices are 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/K141842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141842: Starband, Starlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141842
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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