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Connecta Plus 1 And Connecta Plus 3 2-WAY And 3-WAY Stopcocks

by Ohmeda Medical

510(k) K974083

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

13 ongoing

This device is named in the recall

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 · Traditional NumberK974083 Date13 Jan 1998ClearedStatusActive

Recalls

13 recalls · 13 ongoing · FDA

    • Ongoing Z-2514-2026 FDA Class II initiated 21 May 2026

    Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

    • Ongoing Z-1509-2025 FDA Class II initiated 20 Feb 2025

    Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

  • 11 recalls, same reason

    • Ongoing Z-1433-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1441-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1437-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1439-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1435-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1431-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1432-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1440-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1438-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1434-2022 FDA Class II initiated 9 May 2022
    • Ongoing Z-1436-2022 FDA Class II initiated 9 May 2022

    May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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  • Withdrawn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
FMG
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Connecta Plus 1 and Connecta Plus 3 2-way and 3-way stopcocks are control valves used in I.V. therapy and hemodynamic pressure monitoring. They are classified as Stopcock, I.V. Set devices.

The devices are supplied in 2-way and 3-way configurations and are regulated under the product code FMG, with a regulation number of 880.5440. They have been cleared by the FDA with a 510(k) number of K974083, and are intended for use in general hospital settings.

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Questions

AI-generated answers, 26 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 are the Connecta Plus stopcocks used for?

    The Connecta Plus stopcocks are used in I.V. therapy and hemodynamic pressure monitoring, as control valves to regulate fluid flow.

  • How are the Connecta Plus stopcocks supplied?

    The Connecta Plus stopcocks are supplied in both 2-way and 3-way configurations to accommodate different clinical needs.

  • What is the regulatory classification of the Connecta Plus stopcocks?

    The Connecta Plus stopcocks are classified as Stopcock, I.V. Set devices, with a product code of FMG and a regulation number of 880.5440.