Cleared Traditional

K131626 - EXCELERON BACTERIAL FILTERS (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131626 · Exceleron Medical · General Hospital
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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

Submission Details

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
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.

Device Classification

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 201
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K131626.
Iso-Gard Filter Straight
K252643 · Teleflex Medical Sdn. Bhd. · May 2026
Ambu® Virobac II® Exhalation Filter
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Besmed Bacterial Filter and HMEF
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Breathing circuit bacterial/viral filter
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Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · Passy-Muir, Inc. · Sep 2023
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258 · Intersurgical , Ltd. · Jun 2023