Cleared Traditional

K111408 - MICROGARD II

K111408 is an FDA 510(k) clearance for MICROGARD II, manufactured by Carefusion Germany 234 GmbH. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K111408 · Carefusion Germany 234 GmbH · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
151d
Days
Class 2
Risk

K111408 is an FDA 510(k) clearance for the MICROGARD II. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Carefusion Germany 234 GmbH (Hoechberg, DE). The FDA issued a Cleared decision on October 17, 2011 after a review of 151 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K111408

510(k) Number K111408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2011
Decision Date October 17, 2011
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 168
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K111408.
FLO-GUARD BREATHING FILTER
K121026 · Intersurgical, Inc. · Nov 2012
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
MEDISIZE RED AND MEDISIZE BLUE
K110246 · Qserve America, Inc. · Nov 2011
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
K102483 · Sunset Healthcare Solutions, LLC · Sep 2011
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010
FIL 1520
K101629 · Glenn Medical Systems, Inc. · Jul 2010