510(k) · Cleared

Cleared

Microgard II

K111408510(k) TraditionalCleared Oct 17, 2011151-day reviewClass II21 CFR 868.5260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carefusion Germany 234 GmbH · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Oct 17, 2011 as substantially equivalent to K934272 (Sensor Medics Corp., 1993) after a 151-day review. Its family tree reaches back 1 generation to 1993.

Decided: Oct 17, 2011
Review: 151 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934272 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK934272 Sensormedics Microgard Microbial FilterSensor Medics Corp. · 1993
This deviceK111408 Microgard IICarefusion Germany 234 GmbH · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934272	Sensormedics Microgard Microbial Filter	Sensor Medics Corp.	1993	—
0 (this device)	K111408	Microgard II	Carefusion Germany 234 GmbH	2011	—

FIG. 1 — Lineage of K111408, 1993–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CAH device

#1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K934272	Sensormedics Microgard Microbial Filter Summary page 2 …d devices-- Change to the existing CareFusion MicroGard filter 5.9 Legally predicate marketed device SensorMedics MicroGard Microbial Filter K934272 Code CAN 5.10 Predicate Device Company CareFusion 5.11 Device Description The CareFusion MicroGard 11filter…	Sensor Medics Corp.	1993	—

Also cleared against K934272: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K934272.

How does its category compare?

All CAH devices

CAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · CAH

2in 2024

2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2007high 281 (2011) · low 111 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAH

1in 2025

2007high 6 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · CAH

77in 2025

2007high 98 (2014) · low 9 (2011)2025

MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	32
2008	1	—	0	27
2009	4	111	0	18
2010	5	216	2	40
2011	3	281	0	9
2012	3	212	0	16
2013	1	—	1	47
2014	4	250	1	98
2015	2	—	0	51
2016	0	—	0	34
2017	1	—	1	29
2018	0	—	0	33
2019	2	—	0	30
2020	2	—	0	33
2021	2	—	0	56
2022	3	204	6 (6)	67
2023	3	237	0	40
2024	2	—	0	51
2025	0	—	1 (1)	77
2026	2	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111408 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111408: Microgard II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111408

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026