BD Alaris System with Guardrails Suite MX v12.1.2
FDA 510(k) K211218 · Carefusion 303, Inc.
510(k) numberK211218
Submission
- Device name
- BD Alaris System with Guardrails Suite MX v12.1.2
- Applicant
- Carefusion 303, Inc.
San Diego, CA, US - Received
- April 23, 2021
- Decision date
- July 21, 2023
- 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
Other 510(k)s with product code FRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| 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 |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | 04/25/2025SE |
| 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 System with Guardrails Suite MX v12.1.2 cleared by the FDA?
BD Alaris System with Guardrails Suite MX v12.1.2 (K211218) received a 510(k) decision of Substantially Equivalent on July 21, 2023, 819 days after the submission was received.
What is the product code of K211218?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.