FDA product code OAN: Orthosis, Cranial, Laser Scan
OAN is the FDA product code for orthosis, cranial, laser scan. It is a Class II device, regulated under 21 CFR 882.5970 and reviewed by the Neurology panel. FDA has cleared 23 510(k) submissions under OAN, 2 in the last five years, from 5 different applicants. The average 510(k) review took 101 days (median 84); 52 days on average over the last three years.
Definition
A cranial orthosis is a device that 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. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Cranial, Laser Scan |
| Device class | Class II |
| Regulation | 21 CFR 882.5970 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for OAN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 44 |
| 2021 | 2 | 150 |
| 2024 | 1 | 28 |
| 2025 | 1 | 76 |
Compare with all 510(k) review times · Search every OAN clearance
Top OAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthomerica Products, Inc. | 17 | 2024-03-15 |
| Cranial Technologies, Inc. | 2 | 2025-03-17 |
| Boston Brace Intl., Inc. | 2 | 2008-01-22 |
| Biosculptor Corporation | 1 | 2009-01-27 |
| Hanger Prosthetics & Orthotics, Inc. | 1 | 2008-01-09 |
Most recent OAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K244056 | Cranial Technologies, Inc. | DOC Band 3D | 2025-03-17 | 76 |
| K240466 | Orthomerica Products, Inc. | STARband 3D | 2024-03-15 | 28 |
| K211376 | Orthomerica Products, Inc. | STARband | 2021-08-17 | 105 |
| K203098 | Orthomerica Products, Inc. | STARband, STARlight, St. Louis Band | 2021-04-27 | 195 |
| K180109 | Orthomerica Products, Inc. | STARband, STARlight, St. Louis Band | 2018-03-01 | 44 |
Recalls for OAN devices
openFDA lists no recalls for product code OAN.
Frequently asked questions
What is FDA product code OAN?
OAN is the FDA product code for orthosis, cranial, laser scan. It is a Class II device, regulated under 21 CFR 882.5970 and reviewed by the Neurology panel.
What device class is OAN?
Class II, regulation 21 CFR 882.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAN?
Across 23 cleared submissions the average was 101 days from receipt to decision (median 84).
Which companies have the most OAN clearances?
Orthomerica Products, Inc. (17); Cranial Technologies, Inc. (2); Boston Brace Intl., Inc. (2); Biosculptor Corporation (1); Hanger Prosthetics & Orthotics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAN
- Run a recall and safety report across every OAN manufacturer
- Watch product code OAN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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