K223607 is an FDA 510(k) clearance for the Plum Duo™ Infusion System. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 24, 2023, 265 days after receiving the submission on December 2, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K223607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2022 |
| Decision Date | August 24, 2023 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |