Microgard II

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

510(k) Number

K111408 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

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

• Micro I

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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 Microgard II used for?

  The Microgard II is designed for use in anesthesiology applications to filter bacteria and viruses from breathing circuit gases, helping reduce the risk of cross-contamination during respiratory procedures.

• Is the Microgard II sterile or non-sterile, and is it reusable?

  The Microgard II is supplied as a non-sterile, single-use device, meaning it is not sterilized before distribution and must be discarded after one use to maintain safety and performance.

• Who manufactures the Microgard II and where is it made?

  The Microgard II is manufactured by Carefusion Germany 234 GmbH at their facility located at Leibnizstrasse 7, 97204 Hoechberg, Germany.

• What regulatory pathway was used for the Microgard II’s market authorization?

  The Microgard II received FDA 510(k) clearance (K111408) on October 17, 2011, as substantially equivalent to a legally marketed predicate device under regulation number 868.5260.