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 Mar 1, 2018 as substantially equivalent to K151979 (Orthomerica Products, Inc., 2015) and 1 other predicate after a 44-day review. Its family tree reaches back 12 generations to 2000. 3 later devices descend from it.
- Decided
- Mar 1, 2018
- Review
- 44 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K001167 (2000). 22 ancestors in all, the oldest DEN980001 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 8 generations between
- 3 generations backK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- 2 generations backK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- 1 generation backK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- This deviceK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK213587 MyCRO BandOtto Bock Healthcare LP · 2022
- Descendant · cites it directly · 0 of its ownK193383 SnugKapHeadstart, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201426 MyCRO BandOtto Bock Healthcare LP · 2021
Show all 12 generations
- Root · 12 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 11 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 10 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 9 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 8 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 7 generations backK124023 StarbandOrthomerica Products, Inc. · 2013
- 6 generations backK133250 StarlightOrthomerica Products, Inc. · 2014
- 5 generations backK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- 4 generations backK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- 3 generations backK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- 2 generations backK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- 1 generation backK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- This deviceK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −11 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −10 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −9 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −8 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −7 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| −6 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| −5 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| −4 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| −3 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| −2 | K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| −1 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| 0 (this device) | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
| +1 | K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022 | — |
| +1 | K193383 | SnugKap | Headstart, Ltd. | 2021 | — |
| +1 | K201426 | MyCRO Band | Otto Bock Healthcare LP | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K151979 | STARband, STARlightSummary page 4…aser Scan) Secondary: MVA (Cranial Orthosis) Classification: 21 CFR 882.5970, Cranial Orthosis, Class II III. Predicate Device K151979 STARband, STARlight Product Code OAN, MVA K161138 St. Louis Band Pro… | 2015 |
| * | K161138 | St. Louis BandSummary page 4…21 CFR 882.5970, Cranial Orthosis, Class II III. Predicate Device K151979 STARband, STARlight Product Code OAN, MVA K161138 St. Louis Band Product Code OAN, MVA IV. Description of Device Modification The proposed device… | 2016 |
What descends from it? (3)
3 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 18 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K213587 (Otto Bock Healthcare LP, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K151979.
How does its category compare?
All OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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/K180109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180109: 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/K180109
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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