510(k) · Cleared
ClearedLoma Linda University Medical Center (Llumc) Cranial Remolding Helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rehabilitation Institute,Loma Linda University Med · MVA Orthosis, Cranial
Cleared on Jan 13, 2003 as substantially equivalent to K003035 (Children'S Hospital & Medical Center, 2001) after an 81-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jan 13, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003035 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003035 Clarren HelmetChildren'S Hospital & Medical Center · 2001
- This deviceK023572 Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetRehabilitation Institute,Loma Linda University Med · 2003
- Descendant · cites it directly · 0 of its ownK070694 Ccro (Craniocephalic Custom Remolding Orthosis)Mike Miner · 2007
Most influential descendants
Showing 1 of 1 · See all- K070694Ccro (Craniocephalic Custom Remolding Orthosis)Mike Miner · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003035 | Clarren Helmet | Children'S Hospital & Medical Center | 2001 | — |
| 0 (this device) | K023572 | Loma Linda University Medical Center (Llumc) Cranial Remolding Helmet | Rehabilitation Institute,Loma Linda University Med | 2003 | — |
| +1 | K070694 | Ccro (Craniocephalic Custom Remolding Orthosis) | Mike Miner | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K003035 | Clarren HelmetSummary page 2…6. Technological Characteristics: The LLUMC Cranial Remolding Helmet has the same technological characteristics as the predicate device, the Clarren Helmet, K003035. Both cranial helmets are custom-made to the requirements of each individual infant. The assembly of both helmets begin… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070694 | Ccro (Craniocephalic Custom Remolding Orthosis) | 2007 | 0 |
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?
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 LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023572: Loma Linda University Medical Center (Llumc) Cranial Remolding Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023572
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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