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Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

by Ivenix, Inc.

510(k) K213089

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK213089 Date10 Nov 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ivenix Infusion System LVP Epidural Administration Set NRFit Connector is a sterile, single-use fluid delivery component designed for low-volume epidural infusion. It integrates a primary inlet tubing with a vented spike, a pumping cassette, and outlet tubing ending in an ISO 80369-6:2013 compliant NRFit connector, facilitating precise fluid administration to patients.

This set is intended for use with the Ivenix Infusion System in general hospital settings. Supplied sterile and intended for single-use, the NRFit connector ensures compatibility with patient access devices while adhering to international safety standards. The device received FDA 510(k) clearance under classification FPA, with a clearance number of K213089, and is manufactured by Ivenix, Inc.

Other devices from Ivenix, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use case for the Ivenix Infusion System LVP Epidural Administration Set NRFit Connector in clinical settings?

    This set is specifically designed for low-volume epidural infusion, meaning it delivers precise, controlled fluid doses directly to the epidural space for procedures in general hospital settings. The NRFit connector ensures compatibility with patient access devices, making it suitable for scenarios where accurate fluid administration is critical, such as pain management or regional anesthesia.

  • How is the Ivenix Infusion System LVP Epidural Administration Set NRFit Connector supplied, and what does that mean for its reuse?

    The set is supplied sterile and intended for single-use only, as explicitly stated in the manufacturer’s description. This means each unit is packaged for one-time clinical use to maintain sterility and safety standards, preventing contamination or cross-infection risks.

  • What connector type does this infusion set use, and why is that important?

    The set features an ISO 80369-6:2013 compliant NRFit connector on the outlet tubing. This standardized connector ensures secure, leak-proof attachment to patient access devices while reducing the risk of misconnections—a critical safety feature in medical devices, especially for high-risk procedures like epidural infusions.

  • Is this device compatible with the Ivenix Infusion System, and if so, how does that integration work?

    Yes, this set is intended for use exclusively with the Ivenix Infusion System, as noted in the description. The integration includes a primary inlet tubing, vented spike, and pumping cassette, all of which work together with the system to deliver low-volume fluids precisely to the epidural space, ensuring accurate dosing and reliable performance.

  • What regulatory pathway did the Ivenix Infusion System LVP Epidural Administration Set NRFit Connector follow for FDA clearance?

    The device received FDA 510(k) clearance under classification FPA with clearance number K213089, following a Special review by the Orthopaedic and Rehabilitation Devices Panel (HO). The determination was that it is substantially equivalent to a predicate device, meaning it met the agency’s requirements for safety and effectiveness without requiring a full de novo process.