TNI Clear-Guard 3 angled breathing filter (1545020)
FDA 510(k) K223258 · Intersurgical , Ltd.
510(k) numberK223258
Submission
- Device name
- TNI Clear-Guard 3 angled breathing filter (1545020)
- Applicant
- Intersurgical , Ltd.
Berkshire, GB - Received
- October 21, 2022
- Decision date
- June 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
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| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| 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 |
|---|---|---|
| K141087 | Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled HmefCAH · Traditional | 02/12/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | 06/04/2014SE |
| K121747 | Facefit and Facefit Ported Non-Invasive Ventilation MasksBZD · Traditional | 03/14/2013SE |
| K122077 | ManometerCAP · Traditional | 01/10/2013SE |
| K122075 | Disposable Gas Sampling Line with and Without In-Line FilterCCK · Traditional | 12/20/2012SE |
| K121026 | Flo-Guard Breathing FilterCAH · Traditional | 11/02/2012SE |
| K092451 | Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger…CAH · Traditional | 10/29/2010SE |
| K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model…BZE · Traditional | 05/18/2010SE |
| K092409 | Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear…CAH · Traditional | 03/10/2010SE |
| K032322 | Clear-Therm Micro Hme, Model 1441CAH · Traditional | 05/13/2004SE |
Questions and answers
When was TNI Clear-Guard 3 angled breathing filter (1545020) cleared by the FDA?
TNI Clear-Guard 3 angled breathing filter (1545020) (K223258) received a 510(k) decision of Substantially Equivalent on June 15, 2023, 237 days after the submission was received.
What is the product code of K223258?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.