510(k) · Cleared
ClearedMichigan Cranial Reshaping Orthosis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danmar Products, Inc. · MVA Orthosis, Cranial
Cleared on Jan 6, 2010 as substantially equivalent to K072566 (Hanger Prosthetics & Orthotics, Inc., 2008) and 2 other predicates after a 330-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jan 6, 2010
- Review
- 330 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN980001 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
- 2 generations backK014012 Doc BandCranial Technologies, Inc. · 2002
- 1 generation backK072566 Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008
- This deviceK090341 Michigan Cranial Reshaping OrthosisDanmar Products, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band | Cranial Technologies, Inc. | 1998 | — |
| −2 | K014012 | Doc Band | Cranial Technologies, Inc. | 2002 | — |
| −1 | K072566 | Hanger Cranial Band | Hanger Prosthetics & Orthotics, Inc. | 2008 | — |
| 0 (this device) | K090341 | Michigan Cranial Reshaping Orthosis | Danmar Products, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K072566 | Hanger Cranial BandSummary page 1…ial Reshaping Orthosis is substantially equivalent to the Hanger Cranial Band, cleared for US commercialization via K072566 on January 9, 2008, the Boston Band Cranial Remolding Orthosis, cleared for US… | 2008 |
| * | K072862 | Boston-Band Cranial Remodling OrthosisSummary page 1…on via K072566 on January 9, 2008, the Boston Band Cranial Remolding Orthosis, cleared for US commercialization via K072862 on January 22, 2008 and the Michigan Cranial Helmet, cleared for US commercialization via… | 2008 |
| * | K003630 | Danmar Products Michigan Cranial HelmetSummary page 1…ercialization via K072862 on January 22, 2008 and the Michigan Cranial Helmet, cleared for US commercialization via K003630, May 29, 2001. Device Description: The Danmar Products Michigan Cranial Reshaping Orthosis a… | 2001 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K072566.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription
use to apply pressure to prominent regions of an infant's cranium in order to improve
cranial symmetry and/or shape. A mold is made of the baby's head to create the
orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of
the infant's head to create the mold. The device is indicated for infants from 3 to 18
months of age, with moderate to severe nonsynostotic positional plagiocephaly,
including infants with plagiocephalic and brachycephalic shaped heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090341: Michigan Cranial Reshaping Orthosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090341
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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