Cleared Traditional

K241339 - Besmed Bacterial Filter and HMEF

K241339 is an FDA 510(k) clearance for Besmed Bacterial Filter and HMEF, manufactured by Besmed Health Business Corp. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K241339 · Besmed Health Business Corp · General Hospital
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Nov 2024
Decision
185d
Days
Class 2
Risk

K241339 is an FDA 510(k) clearance for the Besmed Bacterial Filter and HMEF. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on November 14, 2024 after a review of 185 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 Besmed Health Business Corp devices

FDA 510(k) Submission Details - K241339

510(k) Number K241339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2024
Decision Date November 14, 2024
Days to Decision 185 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
56d slower than avg
Panel avg: 129d · This submission: 185d
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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K241339.
Iso-Gard Filter Straight
K252643 · Teleflex Medical Sdn. Bhd. · May 2026
Ambu® Virobac II® Exhalation Filter
K251583 · Ambu A/S · Apr 2026
Breathing circuit bacterial/viral filter
K222917 · Shaoxing Haitech Medical Products Co., Ltd. · Feb 2024
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
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023