Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FRN | K141789 |
| Aug 31, 2026 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL Open, Classified |
FRN | K242390 |
| Aug 31, 2026 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS Open, Classified |
FRN | K242390 |
| Jul 10, 2026 | ICU Medical, Inc. ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump Open, Classified |
FRN | K242114 |
| Jul 10, 2026 | ICU Medical, Inc. ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump Open, Classified |
FRN | K223607 |
| Jun 5, 2026 | ICU Medical, Inc. Plum Duo Precision IV Pump, 40002-0403 Open, Classified |
FRN | K242115 |
| Jun 5, 2026 | ICU Medical, Inc. Plum Duo Infusion Pump, 40002-0401 Open, Classified |
FRN | K223607 |
| Jun 5, 2026 | ICU Medical, Inc. Plum Solo Precision IV Pump, 40001-0401 Open, Classified |
FRN | K242114 |
| Jun 3, 2026 | Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Open, Classified |
FRN | K183311 |
| May 29, 2026 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Open, Classified |
FRN | K183311 |
| May 29, 2026 | Fresenius Kabi USA, LLC The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. Open, Classified |
FRN | K183311 |
| Mar 26, 2026 | CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Open, Classified |
FRN | K023264 K041241 +4 |
| Feb 13, 2026 | Baxter Healthcare Corporation Brand Name: Spectrum IQ
Product Name: Infusion Pump
Model/Catalog Number: 3570009
Software Version: N/A
Product Description: Infusion Pump, one unit per carton
Component: N/A Open, Classified |
FRN | K251636 |
| Jan 29, 2026 | CareFusion 303, Inc. BD Alaris" Pump Module model 8100
UDI-DI code: 10885403810046
The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent admi Open, Classified |
FRN | K211218 |
| Jan 16, 2026 | Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Open, Classified |
FRN | K251640 |
| Jan 16, 2026 | ICU Medical, Inc. ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) Open, Classified |
FRN | K242114 |
| Jan 16, 2026 | ICU Medical, Inc. ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) Open, Classified |
FRN | K242115 |
| Jan 16, 2026 | ICU Medical, Inc. ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) Open, Classified |
FRN | K223607 |
| Jan 15, 2026 | ICU Medical, Inc. Plum Duo Infusion System, List Number 40002-04-01 Open, Classified |
FRN | K223607 |
| Jan 12, 2026 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. Open, Classified |
FRN | K183311 |
| Dec 16, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. Open, Classified |
FRN | K183311 |
| Dec 3, 2025 | Fresenius Kabi USA, LLC IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. Open, Classified |
FRN | K183311 |
| Dec 1, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Open, Classified |
FRN | K183311 |
| Nov 20, 2025 | CareFusion 303, Inc. BD Alaris infusion Pump Module 8100, REF: 8100;
KIT, BEZEL ASSY 8100BD, REF: 49000437;
KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.
Used with the following new and updated documents: BD Alaris Infu Open, Classified |
FRN | K211218 |
| Oct 28, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Open, Classified |
FRN | K183311 |
| Aug 29, 2025 | Baxter Healthcare Corporation Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Open, Classified |
FRN | None listed |
| Aug 29, 2025 | Baxter Healthcare Corporation Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump Open, Classified |
FRN | K242390 |
| Aug 29, 2025 | Baxter Healthcare Corporation Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Open, Classified |
FRN | K211122 |
| Aug 22, 2025 | Baxter Healthcare Corporation Spectrum IQ Infusion Pump, Product Code 3570009 Open, Classified |
FRN | K230041 |
| Aug 14, 2025 | Baxter Healthcare Corporation Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS Open, Classified |
FRN | K211122 |
| Aug 6, 2025 | CareFusion 303, Inc. BD Alaris Pump Infusion Sets
REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;
REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Val Open, Classified |
FRN | K022209 |
| Aug 6, 2025 | ICU Medical, Inc. Plum Duo Infusion System, List Number: 400020401 Open, Classified |
FRN | K223607 |
| Aug 6, 2025 | CareFusion 303, Inc. BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions Open, Classified |
FRN | K211218 |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25. Open, Classified |
FRN | K183311 |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25. Open, Classified |
FRN | K183311 |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20. Open, Classified |
FRN | K183311 |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25. Open, Classified |
FRN | K183311 |
| Jun 18, 2025 | ICU Medical, Inc. ICU Medical Plum Solos, Item number 400011001; infusion pump Open, Classified |
FRN | None listed |
| Jun 18, 2025 | ICU Medical, Inc. ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001
, and 3) 400021003; infusion pump Open, Classified |
FRN | K223607 |
| Jun 12, 2025 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, product code 40800BAXUS, Open, Classified |
FRN | K242390 |
| Jun 6, 2025 | Zyno Medical LLC Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Jun 6, 2025 | Zyno Medical LLC Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Jun 6, 2025 | Zyno Medical LLC Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| Jun 6, 2025 | Zyno Medical LLC Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | K100705 K130690 |
| May 20, 2025 | Baxter Healthcare Corporation Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS Open, Classified |
FRN | K211122 |
| May 7, 2025 | Smiths Medical ASD, Inc. CADD-Solis VIP Ambulatory Infusion Pump;
Model/Number:
21-2120-0100-02
21-2120-0100-03
21-2120-0100-06
21-2120-0100-232
21-2120-0100-233
21-2120-0100-50
21-2120-0100-51
21-2120-0100-95
21-2120-0102- Open, Classified |
FRN | K111275 |
| May 5, 2025 | Smiths Medical ASD, Inc. CADD Solis VIP Ambulatory Infusion Pump Models:
1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL
MODE, 1/EA, Model Number: 21-2127-0105-01;
2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLI Open, Classified |
FRN | K111275 |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Open, Classified |
FRN | K242390 |
| Mar 6, 2025 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Open, Classified |
FRN | K230041 |
| Mar 6, 2025 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX Open, Classified |
FRN | K133801 |
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