Class Class II
BD Alaris Infusion System with Guardrails Suite MX (K243855)
Description
BD Alaris Infusion System with Guardrails Suite MX by Carefusion 303, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243855
Clearance Date2025-04-25
Clearance TypeTraditional
Product CodeFRN
Regulation Number880.5725
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243855
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BD Alaris Infusion System with Guardrails Suite MX (K243855) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023 |
Trace the full predicate network for K243855
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.