Cleared Traditional

K131626 - EXCELERON BACTERIAL FILTERS

K131626 is an FDA 510(k) clearance for EXCELERON BACTERIAL FILTERS, manufactured by Exceleron Medical. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K131626 · Exceleron Medical · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
267d
Days
Class 2
Risk

K131626 is an FDA 510(k) clearance for the EXCELERON BACTERIAL FILTERS. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Exceleron Medical (St. Paul, US). The FDA issued a Cleared decision on February 26, 2014 after a review of 267 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.

View all Exceleron Medical devices

FDA 510(k) Submission Details - K131626

510(k) Number K131626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date February 26, 2014
Days to Decision 267 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
138d slower than avg
Panel avg: 129d · This submission: 267d
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 140
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K131626.
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
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
K132679 · Galemed Corp. · Apr 2014
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014
HYRDROMAX HMEF
K130664 · A-M Systems · Jun 2013
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K121382 · Westmed, Inc. · Dec 2012