FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Alaris Infusion System with Guardrails Suite MX
K Number: K243855
·
Decision Apr 25, 2025
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
1
Review Days
130
Basic Information
- Device Name
- BD Alaris Infusion System with Guardrails Suite MX
- K Number
- K243855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CareFusion 303, Inc.
- Date Received
- December 16, 2024
- Decision Date
- April 25, 2025
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
Plum Duo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
RemunityPRO Pump for Remodulin® (treprostinil) Injection
FDA 510(k)
FDA Class 2
·General Hospital
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
FDA 510(k)
FDA Class 2
·General Hospital
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
FDA 510(k)
FDA Class 2
·General Hospital