510(k) · Cleared
ClearedDanmar Products Cranial Adjustive Prosthesis
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 Oct 31, 2003 as substantially equivalent to K003630 (Danmar Products, Inc., 2001) after a 743-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Oct 31, 2003
- Review
- 743 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003630 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003630 Danmar Products Michigan Cranial HelmetDanmar Products, Inc. · 2001
- This deviceK013452 Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003630 | Danmar Products Michigan Cranial Helmet | Danmar Products, Inc. | 2001 | — |
| 0 (this device) | K013452 | Danmar Products Cranial Adjustive Prosthesis | Danmar Products, Inc. | 2003 | — |
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? (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 |
|---|---|---|---|
| * | K003630 | Danmar Products Michigan Cranial HelmetSummary page 1…approved evaluation of an automatic Class 111 designation, and to the Michigan Cranial Helmet cleared for commercial distribution per K003630. (8001 783-1998 Device Description: (734)761-1990 The Danmar Products Cranial Adjustive Prosthesis is construc… | 2001 |
| * | — | Cranial Technologies Dynamic Orthotic Cranioplasty--DOC Band Named without a submission number |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K003630.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Cranial Adjustive Prosthesis is intenc ?( for prescription use to be used to apply pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 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/K013452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013452: Danmar Products Cranial Adjustive Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026