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Molded Cranial Helmet

by Fairview Orthopedic Laboratory

510(k) K012920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012920 Date28 Nov 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MVA
Device Class
Class II
Regulation
21 CFR Part 882.5970
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Molded Cranial Helmet is a cranial orthosis designed to apply graduated pressure to an infant’s skull. It is classified as an orthotic device intended to correct cranial deformities, including positional plagiocephaly, brachycephaly, and scaphocephaly in children aged 3 to 18 months. The device reshapes the skull by redistributing pressure to flatten prominent areas and promote symmetrical growth.

This device is supplied as a custom-molded, single-use orthosis and is regulated under FDA 510(k) clearance (K012920) as a Class II medical device under regulation 882.5970. It is intended for use in clinical settings, such as neurology or pediatric care, and requires proper fitting by a healthcare professional. Storage and handling instructions are manufacturer-specific, though the device is not sterile and must be used in accordance with clinical guidelines.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What cranial deformities does the Molded Cranial Helmet treat?

    The device is designed to correct positional plagiocephaly (asymmetrical skull flattening), brachycephaly (wide, flattened back of the head), and scaphocephaly (elongated skull) in infants aged 3 to 18 months. It applies graduated pressure to reshape the skull by redistributing forces to flatten prominent areas and encourage symmetrical growth.

  • Is the Molded Cranial Helmet reusable or single-use?

    This device is supplied as a single-use orthosis. It is custom-molded for each patient and intended for one-time clinical application. Reuse is not recommended as it may compromise efficacy and hygiene.

  • Does the Molded Cranial Helmet require sterilization before use?

    No, the device is not sterile and is not intended for sterile procedures. It must be handled in accordance with clinical guidelines for non-sterile orthotic devices, ensuring proper hygiene before fitting.

  • Who should fit the Molded Cranial Helmet, and where is it used?

    The helmet must be fitted by a healthcare professional in clinical settings such as neurology or pediatric care. Proper sizing and application are critical to ensure the device achieves the intended skull reshaping without discomfort or complications.

  • What regulatory pathway does the Molded Cranial Helmet follow?

    The device is classified as a Class II medical device under FDA regulation 882.5970 and has received 510(k) clearance (K012920) as substantially equivalent to a predicate device. It is intended for use in the U.S. under FDA oversight.