# K111408: Microgard II

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Oct 17, 2011 after 151 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934272 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934272: Sensormedics Microgard Microbial Filter, Sensor Medics Corp. (1993) Summary page 2.

## Indications for use
The CareFusion MicroGard® II filter series is indicated for use in prevention of contamination of pulmonary function testing equipment and associated valves and hoses by aerosols and particulates which may be present in a patient's exhaled gas volumes. The MicroGard® II filter should be used only on patients with a minimum body weight of 27.5 kg.

Source page: https://510kreport.com/device/K111408
Methodology: https://510kreport.com/methodology