Besmed Bacterial Filter and HMEF
FDA 510(k) K241339 · Besmed Health Business Corp
510(k) numberK241339
Submission
- Device name
- Besmed Bacterial Filter and HMEF
- Applicant
- Besmed Health Business Corp
New Taipei City, TW - Received
- May 13, 2024
- Decision date
- November 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | Ambu A/S | 04/30/2026SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerCAH · Traditional | Pall Corporation | 11/16/2021SE |
More from Pall Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K172804 | Besmed Peak Flow MeterBZH · Traditional | 01/11/2018SE |
| K160112 | Besmed PEEP ValveBYE · Traditional | 04/29/2016SE |
| K150591 | Besmed Reusable Jet NebulizerCAF · Traditional | 06/30/2015SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | 09/03/2014SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | 06/19/2014SE |
| K133873 | Triball Incentive SpirometerBWF · Traditional | 04/04/2014SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | 11/10/2009SE |
| K031374 | Besmed Various Models of TENS, BE-550/BE-660GZJ · Traditional | 11/28/2003SE |
| K031375 | Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580IPF · Traditional | 11/20/2003SE |
Questions and answers
When was Besmed Bacterial Filter and HMEF cleared by the FDA?
Besmed Bacterial Filter and HMEF (K241339) received a 510(k) decision of Substantially Equivalent on November 14, 2024, 185 days after the submission was received.
What is the product code of K241339?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.