Ivenix Infusion System (IIS)— 510(k) K183311
Substantially EquivalentIvenix, Inc.
FDA 510(k) clearance K183311 for Ivenix Infusion System (IIS), Substantially Equivalent on 2019-06-07. Applicant: Ivenix, Inc.. Device class: 2.
Clearance details
- Applicant
- Ivenix, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Andover, MA, US
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More clearances from Ivenix, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K183311
K-number listed on FDA's recall record- Z-2223-2026 — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Z-2224-2026 — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Z-1048-2026 — Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Z-0885-2026 — Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Z-0586-2026 — 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.
- Z-0848-2026 — Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Z-0378-2026 — Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Z-2232-2025 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
- Z-2233-2025 — LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
- Z-2234-2025 — LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
- Z-2235-2025 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- Z-1869-2025 — IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
- Z-1019-2025 — Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
- Z-0763-2025 — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Z-3153-2024 — Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
- Z-2721-2024 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
- Z-1484-2024 — LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Z-0549-2024 — Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
- Z-1283-2024 — LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Z-1313-2023 — Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183311.
Data sourced from openFDA. This site is unofficial and independent of the FDA.