510(k) · Cleared
ClearedClarren Helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Children'S Hospital & Medical Center · MVA Orthosis, Cranial
Cleared on Jun 6, 2001 after a 251-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 6, 2001
- Review
- 251 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK003035 Clarren HelmetChildren'S Hospital & Medical Center · 2001
- Descendant · cites it directly · 1 of its ownK023572 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
- Descendant · cites it directly · 0 of its ownK022273 Cranial Symmetry SystemBeverly Hills Prosthetics Orthotics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK012007 RHS HelmetRestorative Health Svs, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- K023572Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetRehabilitation Institute,Loma Linda University Med · 2003 · cites it directly1descendant
- K070694Ccro (Craniocephalic Custom Remolding Orthosis)Mike Miner · 2007 · cites it directly0descendants
- K022273Cranial Symmetry SystemBeverly Hills Prosthetics Orthotics, Inc. · 2002 · cites it directly0descendants
- K012007RHS HelmetRestorative Health Svs, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003035 | Clarren Helmet | Children'S Hospital & Medical Center | 2001 | — |
| +1 | 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 | — |
| +1 | K022273 | Cranial Symmetry System | Beverly Hills Prosthetics Orthotics, Inc. | 2002 | — |
| +1 | K012007 | RHS Helmet | Restorative Health Svs, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K023572 (Rehabilitation Institute,Loma Linda University Med, 2003) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K003035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003035: Clarren Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003035
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026