510(k) K991437
- Device
- WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
- Applicant
- WELLS JOHNSON CO.
- 510(k) number
- K991437
- Product code
- FRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-30
- Date received
- 1999-04-26
- Regulation
- 880.5725
- Classification name
- Pump, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN RODENBURG
- Address
- 8000 S. Kolb Rd. Tucson AZ US 85706 85706
FDA Registration Numbers#
- 1713468
- 3012302888
- 3016509758
- 1720929
- 3010082909
- 1319639
- 3008692839
- 3018094310
- 2528981
- 1066270
- 3004082685
- 3009754410
- 3008717264
- 3005778453
- 1526611
- 3003098013
- 3005768810
- 3015276780
- 2520313
- 3007939342
- 2523167
- 9610847
- 3008810357
- 3013652261
- 3024706751
- 1045254
- 9612030
- 3000240707
- 3017907746
- 3009211636
- 9617787
- 9615050
- 3011883032
- 3045809869
- 2032098
- 2027804
- 3011688490
- 1055927
- 3008513006
- 3010432890
- 3007738736
- 3004548776
- 1723170
- 1643817
- 1423507
- 3013319212
- 3013764800
- 9610825
- 3008570882
- 3042027705
- 2411512
- 1314492
- 9617594
- 3015192982
- 3004167615
- 3015972753
- 3003927385
- 2032227
- 3013722099
- 3002808022
- 3003144120
- 3013557562
- 1220477
- 1121996
- 1058584
- 2523676
- 1219702
- 9680425
- 3005627859
- 9614279
- 9681819
- 3010293992
- 1123137
- 1220973
- 3008058400
- 1125615
- 3020777588
- 9680741
- 3016798778
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | 2026-07-24 |
| 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 |
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