Sentrysuite Product Line

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

510(k) Number

K113813 ↗

FDA Product Code

BTY

Device Class

Class II

Regulation

21 CFR Part 868.1890

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Sentrysuite Product Line

  Class II

  FDA 510(k) K122699 Active Cleared 19 Nov 2012

• Vyntus Walk

  Class II

  FDA 510(k) K142959 Active Cleared 20 Mar 2015

• Vyntus / SentrySuite Product Line Open recall

  Class II

  FDA 510(k) K150810 Active Cleared 14 Aug 2015

• Micro I

  Class II

  FDA 510(k) K113096 Active Cleared 13 Apr 2012

• Vyntus/ Sentrysuite Product Line

  Class II

  FDA 510(k) K133925 Active Cleared 22 Aug 2014

• Microblab, Microloop

  Class II

  FDA 510(k) K141936 Active Cleared 29 Dec 2014

See all devices from Carefusion Germany 234 GmbH →

• What is the Sentrysuite Product Line used for?

  The Sentrysuite Product Line is used to calculate predicted values and pulmonary function in the field of anesthesiology, providing valuable data for medical professionals.

• Is the Sentrysuite Product Line cleared by the FDA?

  Yes, the Sentrysuite Product Line has been cleared under the FDA 510(k) program with the clearance number K113813, indicating that it is substantially equivalent to a predicate device.

• What type of device is the Sentrysuite Product Line classified as?

  The Sentrysuite Product Line is classified as a class 2 device, which is a moderate-risk device that requires more stringent controls than class 1 devices but less than class 3 devices.