LifeShield Infusion Safety Software Suite
FDA 510(k) K223606 · Icu Medical, Inc.
510(k) numberK223606
Submission
- Device name
- LifeShield Infusion Safety Software Suite
- Applicant
- Icu Medical, Inc.
Lake Forest, IL, US - Received
- December 2, 2022
- Decision date
- August 24, 2023
- 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 |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 03/29/2024SE |
| 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 |
|---|---|---|
| K252130 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2026SE |
| K252006 | OTTO Disinfecting CapQBP · Traditional | 03/27/2026SE |
| K251980 | ClaveQS BagKPE · Traditional | 03/20/2026SE |
| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | 06/05/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
| K223607 | Plum Duo Infusion SystemFRN · Traditional | 08/24/2023SE |
Questions and answers
When was LifeShield Infusion Safety Software Suite cleared by the FDA?
LifeShield Infusion Safety Software Suite (K223606) received a 510(k) decision of Substantially Equivalent on August 24, 2023, 265 days after the submission was received.
What is the product code of K223606?
The FDA product code is PHC – Infusion Safety Management Software, a Class II (moderate risk) device regulated under 21 CFR 880.5725.