Anesthesia Bacteria Filter
FDA 510(k) K801804 · Omnicon Medical Corp.
510(k) numberK801804
Submission
- Device name
- Anesthesia Bacteria Filter
- Applicant
- Omnicon Medical Corp.
Mchenry, IL, US - Received
- July 29, 1980
- Decision date
- August 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| 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 |
More from Great Group Medical Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K823872 | Emergency Tracheostomy KitEWC · Traditional | 01/21/1983SE |
| K820577 | Anesthesia Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K820576 | Mainflow Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K801803 | Mainflow Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K772060 | Protect IV GardFMP · Traditional | 12/20/1977SE |
| K770136 | Disposable Bacteria FilterCAH · Traditional | 02/14/1977SE |
| K770001 | Airway, Berman 40, 60, 80, 90, L00MM'SCAE · Traditional | 01/12/1977SE |
| K760819 | Conductive Anesthesia Breathing CircuitCAI · Traditional | 10/27/1976SE |
| K760149 | Conductive Anesthsia Breath. CircuitCAI · Traditional | 07/19/1976SE |
Questions and answers
When was Anesthesia Bacteria Filter cleared by the FDA?
Anesthesia Bacteria Filter (K801804) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 15 days after the submission was received.
What is the product code of K801804?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.