510(k) · Cleared
ClearedSt. 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 Jul 20, 2016 as substantially equivalent to K063395 (Orthotic & Prosthetic Lab, Inc., 2006) and 1 other predicate after an 89-day review. Its family tree reaches back 11 generations to 2000. 4 later devices descend from it.
- Decided
- Jul 20, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001167 (2000). 21 ancestors in all, the oldest DEN980001 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 7 generations between
- 3 generations backK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- 2 generations backK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- 1 generation backK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- This deviceK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK213587 MyCRO BandOtto Bock Healthcare LP · 2022
- Descendant · 2 generations on · 0 of its ownK193383 SnugKapHeadstart, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK201426 MyCRO BandOtto Bock Healthcare LP · 2021
Show all 11 generations
- Root · 11 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 10 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 9 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 8 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 7 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 6 generations backK124023 StarbandOrthomerica Products, Inc. · 2013
- 5 generations backK133250 StarlightOrthomerica Products, Inc. · 2014
- 4 generations backK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- 3 generations backK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- 2 generations backK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- 1 generation backK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- This deviceK161138 St. Louis BandOrthomerica Products, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018 · cites it directly3descendants
- K213587MyCRO BandOtto Bock Healthcare LP · 2022 · 2 generations on0descendants
- K193383SnugKapHeadstart, Ltd. · 2021 · 2 generations on0descendants
- K201426MyCRO BandOtto Bock Healthcare LP · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −10 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −9 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −8 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −7 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −6 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| −5 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| −4 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| −3 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| −2 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| −1 | K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| 0 (this device) | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| +1 | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
| +2 | K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022 | — |
| +2 | K193383 | SnugKap | Headstart, Ltd. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K063395 | O&P Bivalve Cranial Molding HelmetSummary page 5…reates a precise pathway for the head shape to improve in symmetry and proportion. The St. Louis Band (formally known as the O&P Bivalve Molding Helmet) was released in K063395. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4” polyethylene-polypropylene copolymer plastic with an in… | 2006 |
| * | K151979 | STARband, STARlightSummary page 5…ce. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Both of these shape capture systems are cleared with the STARband predicate device (K151979). 2 of 8 V. State… | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180109 | STARband, STARlight, St. Louis Band | 2018 | 3 |
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 16 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K180109 (Orthomerica Products, Inc., 2018) has gone furthest, with 3 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. 2016, 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 St. Louis Band 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. This 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/K161138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161138: 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/K161138
Report an extraction error
Are you the manufacturer?
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