Cleared Traditional

K132679 - AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER

K132679 is an FDA 510(k) clearance for AF VIRAL/BACTERIAL FILTER, manufactured by Galemed Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K132679 · Galemed Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
233d
Days
Class 2
Risk

K132679 is an FDA 510(k) clearance for the AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Galemed Corp. (Temecula, US). The FDA issued a Cleared decision on April 18, 2014 after a review of 233 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 - K132679

510(k) Number K132679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2013
Decision Date April 18, 2014
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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 K132679.
Breathing circuit bacterial/viral filter
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INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
K141087 · Intersurgical Incorporated · Feb 2015
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
K132709 · Vr Medical · Jul 2014
EXCELERON BACTERIAL FILTERS
K131626 · Exceleron Medical · Feb 2014
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014
HYRDROMAX HMEF
K130664 · A-M Systems · Jun 2013