510(k) Report

FDA applicant

Ivenix, Inc.

North Andover, MA2 decisions2019–202125 recalls

FDA records 2 decisions for Ivenix, Inc. (North Andover, MA) from 2019 to 2021: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Its devices cite 3 predicates, 1 of them its own earlier devices. 25 recalls are linked to its devices, 13 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Ivenix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2026

2022: 4, 1 Class I2023: 3, 2 Class I2024: 4, 4 Class I2025: 11, 4 Class I2026 (partial year): 3, 2 Class I
2019high 11 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Ivenix, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision
  • FRNPump, Infusion1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 20191cites it

What has FDA decided for it lately?

  • K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc. · 2021
  • K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 201913 Class I recalls

All 2 as Ivenix, Inc. →

What has been recalled?

25 recalls linked to its devices; the latest:

  • K183311Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004May 6, 2026Class I
  • K183311LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.May 6, 2026Class I
  • K183311The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Feb 4, 2026Class II
  • K183311Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.Nov 21, 2025Class II
  • K183311Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled…Nov 14, 2025Class I
  • K183311IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing…Nov 3, 2025Class I