510(k) · Cleared
ClearedBoston Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Brace Intl., Inc. · MVA Orthosis, Cranial
Cleared on Aug 22, 2011 as substantially equivalent to K082950 (Orthomerica Products, Inc., 2008) and 2 other predicates after a 74-day review. Its family tree reaches back 4 generations to 2000. 16 later devices descend from it.
- Decided
- Aug 22, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K001167 (2000). 9 ancestors in all, the oldest DEN980001 (1998). 16 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 3 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 2 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 1 generation backK082950 StarbandOrthomerica Products, Inc. · 2008
- This deviceK111609 Boston BandBoston Brace Intl., Inc. · 2011
- Descendant · cites it directly · 15 of its ownK124023 StarbandOrthomerica Products, Inc. · 2013
- Descendant · 2 generations on · 14 of its ownK133250 StarlightOrthomerica Products, Inc. · 2014
- Descendant · 2 generations on · 13 of its ownK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- Descendant · 3 generations on · 10 of its ownK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- Descendant · 4 generations on · 9 of its ownK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K124023StarbandOrthomerica Products, Inc. · 2013 · cites it directly15descendants
- K133250StarlightOrthomerica Products, Inc. · 2014 · 2 generations on14descendants
- K140353Starband and StarlightOrthomerica Products, Inc. · 2014 · 2 generations on13descendants
- K141842Starband, StarlightOrthomerica Products, Inc. · 2014 · 3 generations on10descendants
- K151147STARband, STARlightOrthomerica Products, Inc. · 2015 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −3 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −2 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −1 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| 0 (this device) | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| +1 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| +2 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| +2 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| +3 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| +4 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 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 |
|---|---|---|---|
| * | K082950 | StarbandSummary page 1…" Classification: Class II (Special Controls); OAN, CFR 882.5970 " Classification Name: Cranial Orthosis " Predicate Devices: STARband Cranial Remolding Orthosis - K082950 Boston Band Cranial Remolding Orthosis - K072862 Hanger Cranial Band - K072566 3) Manufacturing Site: 20 Ledin… | 2008 |
| * | K072862 | Boston-Band Cranial Remodling OrthosisSummary page 1…882.5970 " Classification Name: Cranial Orthosis " Predicate Devices: STARband Cranial Remolding Orthosis - K082950 Boston Band Cranial Remolding Orthosis - K072862 Hanger Cranial Band - K072566 3) Manufacturing Site: 20 Ledin Drive, Avon, MA 02322, Telephone: (800) 262-2235, Fa… | 2008 |
| * | K072566 | Hanger Cranial BandSummary page 1…anial Orthosis " Predicate Devices: STARband Cranial Remolding Orthosis - K082950 Boston Band Cranial Remolding Orthosis - K072862 Hanger Cranial Band - K072566 3) Manufacturing Site: 20 Ledin Drive, Avon, MA 02322, Telephone: (800) 262-2235, Facsimile: (800) 634-5048 === Page 2 =… | 2008 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124023 | Starband | 2013 | 15 |
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 11 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K124023 (Orthomerica Products, Inc., 2013) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K082950.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen 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/K111609 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111609: Boston Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111609
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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