Dose IQ Safety Software
FDA 510(k) K230665 · Baxter Healthcare Corporation
510(k) numberK230665
Submission
- Device name
- Dose IQ Safety Software
- Applicant
- Baxter Healthcare Corporation
Deerfield Lake, IL, US - Received
- March 10, 2023
- Decision date
- March 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHC – Infusion Safety Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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.
Other 510(k)s with product code PHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2026SE |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | Becton Dickinson | 06/20/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 08/24/2023SE |
| K211124 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 08/30/2022SE |
| K210075 | Vigilant Software Suite Vigilant Master MedPHC · Traditional | Fresenius Kabi AG | 03/01/2022SE |
| K182092 | BD Intelliport SystemPHC · Traditional | Becton, Dickinson and Company | 04/30/2019SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | Becton, Dickinson & CO | 12/18/2014SE |
| K141193 | Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0PHC · Traditional | Smiths Medical Asd, Inc. | 07/25/2014SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDI · Special | 09/14/2023SE |
Questions and answers
When was Dose IQ Safety Software cleared by the FDA?
Dose IQ Safety Software (K230665) received a 510(k) decision of Substantially Equivalent on March 29, 2024, 385 days after the submission was received.
What is the product code of K230665?
The FDA product code is PHC – Infusion Safety Management Software, a Class II (moderate risk) device regulated under 21 CFR 880.5725.