MasterScreen Paed - Baby Body

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K081823 ↗

FDA Product Code

CCM

Device Class

Class II

Regulation

21 CFR Part 868.1750

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Viasys Healthcare GmbH →

• What types of respiratory conditions can the MasterScreen Paed - Baby Body help diagnose or monitor in infants and young children?

  The MasterScreen Paed - Baby Body is designed for pediatric pulmonary function testing, specifically measuring lung volumes and airway resistance in infants and young children. It supports the diagnosis and management of respiratory conditions by adapting to their unique physiological characteristics, though the exact conditions it aids in diagnosing are not specified in the data. Clinicians use it to assess conditions like asthma, bronchopulmonary dysplasia, or other obstructive/respiratory disorders in this age group.

• Is the MasterScreen Paed - Baby Body intended for use in operating rooms or only clinical settings like pulmonary function labs?

  While the device is primarily intended for clinical settings, the data explicitly mentions its use in anesthesiology, meaning it is also suitable for operating rooms or procedural areas where pediatric respiratory assessments are required during anesthesia. Its design accommodates infants and young children, making it versatile for both diagnostic and intraoperative monitoring.

• How is the MasterScreen Paed - Baby Body supplied, and does it require sterilization between uses?

  The device is supplied as a reusable instrument, meaning it is not single-use. The data does not specify explicit sterility requirements, so proper cleaning and disinfection protocols (as per facility guidelines) would apply to maintain safety between uses. Clinicians should follow manufacturer-recommended reprocessing instructions to ensure hygiene and functionality.

• What regulatory pathway was followed for FDA clearance of the MasterScreen Paed - Baby Body, and when was it approved?

  The device received FDA clearance through a 510(k) submission (K081823), determined to be Substantially Equivalent (SESE) to a predicate device. The clearance was granted on May 18, 2009, under the Anesthesiology advisory committee review. This classification aligns with its use in pediatric pulmonary function testing and anesthesia-related settings.