OAN · Class II · 21 CFR 882.5970

FDA Product Code OAN: Orthosis, Cranial, Laser Scan

Laser-scanned cranial orthoses provide precise, non-invasive treatment for positional plagiocephaly. FDA product code OAN covers cranial orthoses fabricated from digital laser scans of the infant's head.

These custom-fitted helmets use controlled pressure and free space zones to redirect skull growth and correct asymmetric head shape in infants with deformational plagiocephaly and brachycephaly during the period of active skull growth.

OAN devices are Class II medical devices, regulated under 21 CFR 882.5970 and reviewed by the FDA Neurology panel.

Leading manufacturers include Orthomerica Products, Inc., Cranial Technologies, Inc. and Boston Brace Intl., Inc..

Total

Cleared

101d

Avg days

2001

Since

Stable submission activity - 1 submissions in the last 2 years

Review times improving: avg 76d recently vs 103d historically

FDA 510(k) Cleared Orthosis, Cranial, Laser Scan Devices (Product Code OAN)

23 devices

1–23 of 23

Cleared Mar 17, 2025

DOC Band 3D

K244056

Cranial Technologies, Inc.

FDA Product Code OAN: Orthosis, Cranial, Laser Scan

FDA 510(k) Cleared Orthosis, Cranial, Laser Scan Devices (Product Code OAN)

About Product Code OAN - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - OAN Product Code

Related FDA 510(k) Regulatory Insights