510(k) · Cleared
ClearedCcro (Craniocephalic Custom Remolding Orthosis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mike Miner · MVA Orthosis, Cranial
Cleared on Sep 10, 2007 as substantially equivalent to K023572 (Rehabilitation Institute,Loma Linda University Med, 2003) and 2 other predicates after a 181-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Sep 10, 2007
- Review
- 181 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K003035 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK003035 Clarren HelmetChildren'S Hospital & Medical Center · 2001
- 1 generation backK023572 Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetRehabilitation Institute,Loma Linda University Med · 2003
- This deviceK070694 Ccro (Craniocephalic Custom Remolding Orthosis)Mike Miner · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K070694 | Ccro (Craniocephalic Custom Remolding Orthosis) | Mike Miner | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K023572 | Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetSummary page 1…Craniocephalic Custom Remolding Orthtosis Common name: Cranial Helmet Classification name: Cranial Orthosis Predicate Device: LLUMC k023572, Ballert k030669, Clarren k003035 Device Description 'he CCRO is a passive cranial orthosis that allows an infants cranium to im… | 2003 |
| * | K030669 | Providence Molding HelmetSummary page 1…lic Custom Remolding Orthtosis Common name: Cranial Helmet Classification name: Cranial Orthosis Predicate Device: LLUMC k023572, Ballert k030669, Clarren k003035 Device Description 'he CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry… | 2003 |
| * | K003035 | Clarren HelmetSummary page 1…ing Orthtosis Common name: Cranial Helmet Classification name: Cranial Orthosis Predicate Device: LLUMC k023572, Ballert k030669, Clarren k003035 Device Description 'he CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape dur… | 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 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Craniocephalic Custom Remolding Orthosis (CORO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070694: Ccro (Craniocephalic Custom Remolding Orthosis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070694
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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