K211124 is an FDA 510(k) clearance for the Dose IQ Safety Software. This device is classified as a Infusion Safety Management Software (Class II - Special Controls, product code PHC).
Submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on August 30, 2022, 502 days after receiving the submission on April 15, 2021.
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 | K211124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2021 |
| Decision Date | August 30, 2022 |
| Days to Decision | 502 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. |