Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0
FDA 510(k) K141193 · Smiths Medical Asd, Inc.
510(k) numberK141193
Submission
- Device name
- Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0
- Applicant
- Smiths Medical Asd, Inc.
St. Paul, MN, US - Received
- May 8, 2014
- Decision date
- July 25, 2014
- 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 |
| 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 |
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Questions and answers
When was Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0 cleared by the FDA?
Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0 (K141193) received a 510(k) decision of Substantially Equivalent on July 25, 2014, 78 days after the submission was received.
What is the product code of K141193?
The FDA product code is PHC – Infusion Safety Management Software, a Class II (moderate risk) device regulated under 21 CFR 880.5725.