Masterscreen Ios

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

510(k) Number

K101873 ↗

FDA Product Code

BZG

Device Class

Class II

Regulation

21 CFR Part 868.1840

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K113813 Active Cleared 10 May 2012

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  FDA 510(k) K142959 Active Cleared 20 Mar 2015

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  FDA 510(k) K150810 Active Cleared 14 Aug 2015

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  FDA 510(k) K113096 Active Cleared 13 Apr 2012

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  Class II

  FDA 510(k) K133925 Active Cleared 22 Aug 2014

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  FDA 510(k) K141936 Active Cleared 29 Dec 2014

See all devices from Carefusion Germany 234 GmbH →

• What is the primary purpose of the MasterScreen IOS?

  The MasterScreen IOS is a diagnostic spirometer used for pulmonary function testing. It is designed to measure and evaluate respiratory parameters to assist clinicians in the assessment of lung function.

• What is the regulatory status of this device?

  The MasterScreen IOS is classified as a Class 2 medical device under regulation 868.1840. It has received FDA 510(k) clearance, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of the MasterScreen IOS?

  This device is manufactured by Carefusion Germany 234 GmbH, located in Hoechberg, Germany.