K222917 is an FDA 510(k) clearance for the Breathing circuit bacterial/viral filter. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Shaoxing Haitech Medical Products Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on February 15, 2024, 507 days after receiving the submission on September 26, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K222917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | February 15, 2024 |
| Days to Decision | 507 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 |