510(k) K210073
- Device
- Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
- Applicant
- Fresenius Kabi AG
- 510(k) number
- K210073
- Product code
- FRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-01
- Date received
- 2021-01-12
- Regulation
- 880.5725
- Classification name
- Pump, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Keith Dunn
- Address
- Else-Kroner-Str. 1 Bad Homburg DE 61346 61346
FDA Registration Numbers#
- 9617594
- 1423537
- 2024022
- 3004906872
- 2029275
- 3009754410
- 3006575795
- 1526611
- 2528981
- 3003098013
- 1222313
- 2523167
- 2244478
- 3005700264
- 2024064
- 3004986960
- 3008058400
- 2520313
- 3015158050
- 9680787
- 3005778453
- 1066270
- 3015276780
- 9710049
- 9617604
- 3020777588
- 2027804
- 3042027705
- 1047843
- 2032112
- 3018094310
- 2011171
- 9680741
- 3003879246
- 3012302888
- 1319639
- 3002879653
- 1928237
- 1423507
- 1018470
- 3013652261
- 9680425
- 3017636737
- 3003144120
- 2022994
- 1721686
- 3010564249
- 9610847
- 9615908
- 9610825
- 1220477
- 2032862
- 9615050
- 2219920
- 2029015
- 9710593
- 3010273872
- 1921846
- 3004112621
- 3018229072
- 1123137
- 3013764800
- 3024706751
- 3024122953
- 3005627859
- 9617787
- 3000240707
- 9612051
- 1643817
- 3015972753
- 2032227
- 3008513006
- 3004530184
- 1045254
- 9612030
- 1061124
- 3010293992
- 9614279
- 3010291427
- 1420032
Source Documents#
Other 510(k) Records For Product Code FRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | 2026-01-28 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2025-07-28 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | 2025-07-28 |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025-05-28 |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025-04-25 |
| K242115 | Plum Duo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 |
| K242114 | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 |
| K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025-03-11 |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025-01-16 |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies | 2024-12-23 |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | 2024-10-03 |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024-09-05 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | 2024-05-17 |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | 2024-03-29 |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems | 2023-11-03 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases