510(k) · Cleared
ClearedSTARband, STARlight, St. Louis Band
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 Apr 27, 2021 as substantially equivalent to K142141 (Orthomerica Products, Inc., 2015) after a 195-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Apr 27, 2021
- Review
- 195 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001167 (2000). 17 ancestors in all, the oldest DEN980001 (1998). No later device cites it as a predicate yet.
- Root · 9 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 5 generations between
- 3 generations backK133250 StarlightOrthomerica Products, Inc. · 2014
- 2 generations backK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- 1 generation backK142141 Starband, StarlightOrthomerica Products, Inc. · 2015
- This deviceK203098 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 8 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 7 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 6 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 5 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 4 generations backK124023 StarbandOrthomerica Products, Inc. · 2013
- 3 generations backK133250 StarlightOrthomerica Products, Inc. · 2014
- 2 generations backK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- 1 generation backK142141 Starband, StarlightOrthomerica Products, Inc. · 2015
- This deviceK203098 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −8 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −7 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −6 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −5 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −4 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| −3 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| −2 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| −1 | K142141 | Starband, Starlight | Orthomerica Products, Inc. | 2015 | — |
| 0 (this device) | K203098 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K142141 | Starband, StarlightSummary page 7…es and post-operative patients. VI. Predicate and Reference Devices Predicate Device: * STARbando and STARlight* with Cranial Comparison Utility (CCU) - K142141 Reference Devices: * St. Louis Band Cranial Orthosis - K161138 * STARbando and STARlight* with SmartSoc - K1418… | 2015 |
| † | K161138 | St. Louis Band | 2016 |
| † | K141842 | Starband, Starlight | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 17 ancestors has a recall.
How does its category compare?
All OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 STARband, STARlight, and St. Louis Band 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/K203098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203098: STARband, STARlight, St. Louis Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203098
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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