510(k) K904048
- Device
- MULTI DRUG INFUSION SYSTEM
- Applicant
- I-FLOW CORP.
- 510(k) number
- K904048
- Product code
- FRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-01
- Date received
- 1990-09-04
- Regulation
- 880.5725
- Classification name
- Pump, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BARD
- Address
- 2532 White Rd. Irvine CA US 92714 92714
FDA Registration Numbers#
- 2523676
- 3007939342
- 1314417
- 9710049
- 3012302888
- 3024122953
- 3003144120
- 3000240707
- 2024022
- 9610825
- 3013319212
- 1055927
- 3013652261
- 2032112
- 2032862
- 3018229072
- 1722139
- 2032227
- 1220973
- 3036773433
- 1222313
- 1721686
- 3000204189
- 2244478
- 3003927385
- 3004530184
- 1123137
- 1220908
- 9680425
- 1720929
- 3004167615
- 9615050
- 1314492
- 3002808022
- 3016509758
- 3012307300
- 2032098
- 3018094310
- 3013298431
- 1066270
- 1713468
- 9681819
- 3029973819
- 9710593
- 1047843
- 3014732157
- 1054713
- 3010564249
- 9617787
- 3004548776
- 3007738736
- 3017636737
- 3010082909
- 2650143
- 3009211636
- 2027804
- 1219602
- 1018470
- 3005700264
- 3004906872
- 3006575795
- 3010293992
- 1220477
- 3015192982
- 9617594
- 1420032
- 3015158050
- 3008692839
- 1320894
- 9617604
- 1045254
- 2320968
- 1928237
- 3003098013
- 3004491689
- 1219702
- 3010291427
- 2520313
- 3012337868
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | 2025-07-28 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | 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 |
| K242114 | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 |
| K242115 | Plum Duo™ 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