FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Plum Duo Infusion System
K Number: K223607
·
Decision Aug 24, 2023
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
66
Review Days
265
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Plum Duo Infusion System
- K Number
- K223607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icu Medical, Inc.
- Date Received
- December 2, 2022
- Decision Date
- August 24, 2023
- 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.
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)
FDA Class 2
·General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library
FDA 510(k)
FDA Class 2
·General Hospital
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Icu Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Apr 2, 2026 | Substantially Equivalent |
| K252006 | OTTO Disinfecting Cap | Mar 27, 2026 | Substantially Equivalent |
| K251980 | ClaveQS Bag | Mar 20, 2026 | Substantially Equivalent |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Jun 5, 2025 | Substantially Equivalent |
| K242114 | Plum Solo Precision IV Pump | Apr 2, 2025 | Substantially Equivalent |
| K242117 | LifeShield Infusion Safety Software Suite | Apr 2, 2025 | Substantially Equivalent |
| K242115 | Plum Duo Precision IV Pump | Apr 2, 2025 | Substantially Equivalent |
| K243985 | Rio Drug Reconstitution Transfer Device | Jan 22, 2025 | Substantially Equivalent |
| K223606 | LifeShield Infusion Safety Software Suite | Aug 24, 2023 | Substantially Equivalent |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Aug 31, 2018 | Substantially Equivalent |