Filterflo H
FDA 510(k) K011212 · Arc Medical, Inc.
510(k) numberK011212
Submission
- Device name
- Filterflo H
- Applicant
- Arc Medical, Inc.
Scottdale, GA, US - Received
- April 20, 2001
- Decision date
- December 20, 2001
- 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
Other 510(k)s with product code CAH
| 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 |
|---|---|---|
| K090738 | Thermoflo HCH, Thermoflo FilterCAH · Traditional | 07/27/2009SE |
| K063125 | Filterflo Hepa; Thermoflo Hepa (Filter / Hme)CAH · Traditional | 04/13/2007SE |
| K982239 | Circuit GuardCAH · Traditional | 08/14/1998SE |
| K924997 | EddBTR · Traditional | 03/28/1995SE |
| K924627 | Xtend Circuits (TM)CAI · Traditional | 04/07/1993SE |
Questions and answers
When was Filterflo H cleared by the FDA?
Filterflo H (K011212) received a 510(k) decision of Substantially Equivalent on December 20, 2001, 244 days after the submission was received.
What is the product code of K011212?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.