510(k) · Cleared
ClearedCranial Symmetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beverly Hills Prosthetics Orthotics, Inc. · MVA Orthosis, Cranial
Cleared on Sep 9, 2002 as substantially equivalent to K003035 (Children'S Hospital & Medical Center, 2001) after a 56-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Sep 9, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003035 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003035 Clarren HelmetChildren'S Hospital & Medical Center · 2001
- This deviceK022273 Cranial Symmetry SystemBeverly Hills Prosthetics Orthotics, Inc. · 2002
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) | K022273 | Cranial Symmetry System | Beverly Hills Prosthetics Orthotics, Inc. | 2002 | — |
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…substantial equivalence with Cranial Symmetry System to the legally marketed device Clarren Helmet (K003035) per 807.92(a)(3). Device Description: The Cranial Symmetry System provides passive pressure… | 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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K003035.
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 Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants’ 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.
The sale and distribution of the device is restricted to prescription use in accordance with 21 CFR 801.109
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022273: Cranial Symmetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022273
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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