Flexicare Breathing Filters
FDA 510(k) K092218 · Flexicare Medical, Ltd.
510(k) numberK092218
Submission
- Device name
- Flexicare Breathing Filters
- Applicant
- Flexicare Medical, Ltd.
Mid Glam, GB - Received
- July 22, 2009
- Decision date
- October 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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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| 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 |
| 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 |
|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | 09/02/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | 01/16/2026SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | 05/20/2025SE |
| K201666 | Single Use ManometerCAP · Traditional | 11/13/2020SE |
| K191909 | HepaShield Bacterial Viral Breathing System FilterCAH · Traditional | 03/23/2020SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | 12/07/2018SE |
| K163300 | ThermoShield HME FilterCAH · Traditional | 03/22/2017SE |
| K161314 | Flexicare FL-9000U Respiratory Humidifier BaseBTT · Traditional | 07/06/2016SE |
| K160540 | Flexicare Neonatal Heated Wire Breathing SystemBZE · Traditional | 06/23/2016SE |
| K150900 | Flexicare Heated Wire Breathing SystemsBZE · Traditional | 05/15/2015SE |
Questions and answers
When was Flexicare Breathing Filters cleared by the FDA?
Flexicare Breathing Filters (K092218) received a 510(k) decision of Substantially Equivalent on October 6, 2009, 76 days after the submission was received.
What is the product code of K092218?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.