K222622 is an FDA 510(k) clearance for the Disposable Infusion Bag for Parenteral Nutrition. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Beijing L&Z Medical Technology Development Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 16, 2023, 169 days after receiving the submission on August 31, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K222622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2022 |
| Decision Date | February 16, 2023 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE - Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |