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KVO Check Valve Accessory, Model EV-0001

by I-Flow Corp. 510(k)

Active United States

510(k) K984441

Overview

The KVO Check Valve Accessory, Model EV-0001, is a single-patient-use, non-powered mechanical component classified as a Set, Administration, Intravascular device (product code FPA). It functions as a one-way check valve designed to allow free flow under positive differential pressure while preventing backflow under negative differential pressure.

This accessory is supplied as a reusable component for use with the I-Flow One•Step KVO infusion pump. It features a one-piece elastomeric duckbill mechanism housed in polycarbonate and is intended for single-patient use. The device received FDA 510(k) clearance under the General Hospital advisory committee review, classified as Class II with Special Controls.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984441 Date22 Feb 1999ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the KVO Check Valve Accessory, Model EV-0001, specifically designed to do within an infusion setup?

    The KVO Check Valve Accessory, Model EV-0001, is designed as a one-way mechanical check valve that allows fluid to flow freely when positive pressure is applied (e.g., during infusion) while preventing backflow when negative pressure occurs (e.g., during patient withdrawal or aspiration). This ensures continuous infusion while maintaining line integrity for devices like the I-Flow One•Step KVO infusion pump.

  • Is the KVO Check Valve Accessory, Model EV-0001, intended for reuse or single-patient use, and how is it supplied?

    The KVO Check Valve Accessory, Model EV-0001, is explicitly intended for single-patient use only, despite being a reusable component in design. It is supplied as a standalone accessory meant to be paired with the I-Flow One•Step KVO infusion pump, featuring a one-piece elastomeric duckbill mechanism encased in polycarbonate.

  • What type of regulatory pathway did the KVO Check Valve Accessory, Model EV-0001, undergo, and what classification does it hold?

    The device underwent a traditional 510(k) review under the General Hospital (HO) Advisory Committee and was classified as Class II with Special Controls. It was determined to be substantially equivalent to a predicate device, receiving clearance via the FDA’s 510(k) process (K984441) in February 1999.

  • How is the KVO Check Valve Accessory, Model EV-0001, physically constructed, and what materials are used?

    The valve consists of a one-piece elastomeric duckbill mechanism housed within a polycarbonate casing, combining flexibility for valve function with structural durability. The design ensures a tight seal while maintaining ease of fluid flow in the intended direction.