510(k) · Cleared
ClearedCamlab Cranial Orthosis Helmet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosculptor Corporation · OAN Orthosis, Cranial, Laser Scan
Cleared on Jan 27, 2009 as substantially equivalent to K011350 (Orthomerica Products, Inc., 2001) after a 217-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it.
- Decided
- Jan 27, 2009
- Review
- 217 days
- Class
- Class II
- Product code
- OAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011350 (2001). 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011350 Starband Cranial OrthosisOrthomerica Products, Inc. · 2001
- This deviceK081787 Camlab Cranial Orthosis HelmetBiosculptor Corporation · 2009
- Descendant · cites it directly · 15 of its ownK124023 StarbandOrthomerica Products, Inc. · 2013
- Descendant · 2 generations on · 14 of its ownK133250 StarlightOrthomerica Products, Inc. · 2014
- Descendant · 2 generations on · 13 of its ownK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- Descendant · 3 generations on · 10 of its ownK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- Descendant · 4 generations on · 9 of its ownK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K124023StarbandOrthomerica Products, Inc. · 2013 · cites it directly15descendants
- K133250StarlightOrthomerica Products, Inc. · 2014 · 2 generations on14descendants
- K140353Starband and StarlightOrthomerica Products, Inc. · 2014 · 2 generations on13descendants
- K141842Starband, StarlightOrthomerica Products, Inc. · 2014 · 3 generations on10descendants
- K151147STARband, STARlightOrthomerica Products, Inc. · 2015 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011350 | Starband Cranial Orthosis | Orthomerica Products, Inc. | 2001 | — |
| 0 (this device) | K081787 | Camlab Cranial Orthosis Helmet | Biosculptor Corporation | 2009 | — |
| +1 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| +2 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| +2 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| +3 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| +4 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 OAN? 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 OAN device
- #1 K244056 DOC Band 3Dscore 9.3 · 2 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 |
|---|---|---|---|
| * | K011350 | Starband Cranial Orthosis Our reading of the summary gave K001350, FDA’s number for Patient Matched Titanium Alloy Trochlea (Biomet, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Orthomerica STARband”. | 2001 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124023 | Starband | 2013 | 15 |
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 OAN devicesOAN Orthosis, Cranial, Laser Scan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OAN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAN
63in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAN
No recall names OAN since 2007.
Adverse event reports per year · OAN
1in 2020
MAUDE reports naming product code OAN, 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 | 1 | — | 0 | 0 |
| 2008 | 5 | 63 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 63 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081787 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081787: Camlab Cranial Orthosis Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081787
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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