510(k) · Cleared
ClearedO&P Bivalve Cranial Molding Helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthotic & Prosthetic Lab, Inc. · MVA Orthosis, Cranial
Cleared on Dec 22, 2006 as substantially equivalent to K013700 (Precision Prosthetics & Orthotics, Inc., 2002) after a 43-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN980001 (1998). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
- 1 generation backK013700 Orthosis Helmet MoldingPrecision Prosthetics & Orthotics, Inc. · 2002
- This deviceK063395 O&P Bivalve Cranial Molding HelmetOrthotic & Prosthetic Lab, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK213587 MyCRO BandOtto Bock Healthcare LP · 2022
- Descendant · 3 generations on · 0 of its ownK193383 SnugKapHeadstart, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK201426 MyCRO BandOtto Bock Healthcare LP · 2021
Most influential descendants
Showing 5 of 5 · See all- K161138St. Louis BandOrthomerica Products, Inc. · 2016 · cites it directly4descendants
- K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018 · 2 generations on3descendants
- K213587MyCRO BandOtto Bock Healthcare LP · 2022 · 3 generations on0descendants
- K193383SnugKapHeadstart, Ltd. · 2021 · 3 generations on0descendants
- K201426MyCRO BandOtto Bock Healthcare LP · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band | Cranial Technologies, Inc. | 1998 | — |
| −1 | K013700 | Orthosis Helmet Molding | Precision Prosthetics & Orthotics, Inc. | 2002 | — |
| 0 (this device) | K063395 | O&P Bivalve Cranial Molding Helmet | Orthotic & Prosthetic Lab, Inc. | 2006 | — |
| +1 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| +2 | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
| +3 | K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022 | — |
| +3 | K193383 | SnugKap | Headstart, Ltd. | 2021 | — |
| +3 | K201426 | MyCRO Band | Otto Bock Healthcare LP | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K013700 | Orthosis Helmet MoldingSummary page 2…ry about proper positioning. F. PERFORMANCE DATA The O&P Bivalve Cranial Molding Helmet is substantially equivalent to Precisions Orthotic Molding Helmet (K013700). As such, the O&P Cranial Molding Helmet meets the same standards of performance as Precision's Orthotic Molding Helmet and the… | 2002 |
| † | K964992 | DOC Band |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161138 | St. Louis Band | 2016 | 4 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161138 (Orthomerica Products, Inc., 2016) has gone furthest, with 4 descendants 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 | — |
What is it indicated for?
The O&P Bivalve Cranial Molding Helmet is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063395: O&P Bivalve Cranial Molding Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063395
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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