510(k) · Cleared
ClearedOrthosis Helmet Molding
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Prosthetics & Orthotics, Inc. · MVA Orthosis, Cranial
Cleared on Feb 5, 2002 as substantially equivalent to DEN980001 (Cranial Technologies, Inc., 1998) after an 89-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.
- Decided
- Feb 5, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN980001 (1998). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
- This deviceK013700 Orthosis Helmet MoldingPrecision Prosthetics & Orthotics, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK063395 O&P Bivalve Cranial Molding HelmetOrthotic & Prosthetic Lab, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK213587 MyCRO BandOtto Bock Healthcare LP · 2022
- Descendant · 4 generations on · 0 of its ownK193383 SnugKapHeadstart, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K063395O&P Bivalve Cranial Molding HelmetOrthotic & Prosthetic Lab, Inc. · 2006 · cites it directly5descendants
- K161138St. Louis BandOrthomerica Products, Inc. · 2016 · 2 generations on4descendants
- K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018 · 3 generations on3descendants
- K213587MyCRO BandOtto Bock Healthcare LP · 2022 · 4 generations on0descendants
- K193383SnugKapHeadstart, Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band | Cranial Technologies, Inc. | 1998 | — |
| 0 (this device) | K013700 | Orthosis Helmet Molding | Precision Prosthetics & Orthotics, Inc. | 2002 | — |
| +1 | K063395 | O&P Bivalve Cranial Molding Helmet | Orthotic & Prosthetic Lab, Inc. | 2006 | — |
| +2 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| +3 | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
| +4 | K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022 | — |
| +4 | K193383 | SnugKap | Headstart, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 11.9 · 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 |
|---|---|---|---|
| * | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band Our OCR of the scanned summary read K964992, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980001, Dynamic Orthotic Cranioplasty Band; Doc Band (Cranial Technologies, Inc.), granted May 29, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063395 | O&P Bivalve Cranial Molding Helmet | 2006 | 5 |
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 Precision Prosthetics and Orthotics, Inc. orthotic molding helmet is intended to apply passive pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013700: Orthosis Helmet Molding.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013700
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026