BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k) K243855 · Carefusion 303, Inc.
510(k) numberK243855
Submission
- Device name
- BD Alaris Infusion System with Guardrails Suite MX
- Applicant
- Carefusion 303, Inc.
San Diego, CA, US - Received
- December 16, 2024
- Decision date
- April 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
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More from Belmont Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2FRN · Traditional | 07/21/2023SE |
| K171957 | MaxZero Extension Sets with Needless ConnectorFPA · Traditional | 07/19/2017SE |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemDSA · Traditional | 06/22/2017SE |
| K133532 | Alaris System with Guardrails Suite MXFRN · Traditional | 08/21/2014SE |
| K110535 | Alaris PC Unit Module 8000 with Software CorrectionFRN · Traditional | 03/26/2012SE |
| K110809 | Wireless Monitoring SystemDRG · Traditional | 07/05/2011SE |
Questions and answers
When was BD Alaris Infusion System with Guardrails Suite MX cleared by the FDA?
BD Alaris Infusion System with Guardrails Suite MX (K243855) received a 510(k) decision of Substantially Equivalent on April 25, 2025, 130 days after the submission was received.
What is the product code of K243855?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.