K223606 is an FDA 510(k) clearance for the LifeShield™ Infusion Safety Software Suite. This device is classified as a Infusion Safety Management Software (Class II - Special Controls, product code PHC).
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. Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission..
| 510(k) Number | K223606 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 | PHC — Infusion Safety Management Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission. |