K221472 is an FDA 510(k) clearance for the Filter and HME/Filter. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Ningbo Huakun Medical Equipment Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on February 8, 2023, 264 days after receiving the submission on May 20, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K221472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2022 |
| Decision Date | February 08, 2023 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |