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Concord/Portex

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Devices
23

What Concord/Portex makes

Concord/Portex manufactures medical devices for respiratory care, anesthesia, and procedural applications, including suction control valves, heat moisture exchangers, and tracheostomy tubes. Their portfolio also covers anesthesia breathing circuits, needle protection systems for subcutaneous tunneling, and amniocentesis trays for fluid sampling. Additional products include ventilator circuits like the Accu-Vent™ with integrated needle protection and low-profile tracheostomy solutions.

The company’s devices are classified under FDA’s Class I and Class II categories, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, reflecting compliance with US regulatory requirements. The manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue23

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  • Suction Control Valve Ref K892343

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Accu-Vent(Tm) With Needle-Pro(Tm) Ref K912043

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Needle-Pro Cartridge Ref K923127

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Subcutaneous Tunneling Needle And Handles Ref K930218

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Heat Moisture Condenser Ref K923910

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Anesthesia Breathing Circuit Ref K915452

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • New-Vent Ref K911809

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Safety Needle Sheath Ref K904198

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacu-Pro Ref K922445

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Low Profile Tracheostomy Tube Ref K922749

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Steri-Cath(Tm) Ref K902383

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Amniotic Fluid Sampler (Amniocentesis Tray) Ref K896031

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Syringe Tip Cap Ref K911638

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tracheostomy Tube And Cuff Ref K912124

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oral Pharyngeal Cleansing Device Ref K905011

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Dri-Vendt/Provent/Accuvent Arterial Blood Gas Kits Ref K930286

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modified Endobronchial Tube Ref K902116

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Safety Needle Sheath, Modification Ref K911037

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Anesthesia/Respiratory Disposable Mask Ref K891316

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Steri-Cath Mdi Ref K923559

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Steri-Cath-Dl Ref K902687

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • D.I.C. Tracheostomy Tubes & Laryngectomy Tubes Ref K903730

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epidural Minipack Ref K924541

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-23 of 23

Frequently asked questions

How many devices does Concord/Portex have in the registry?

The registry currently lists 23 devices for Concord/Portex. Devices recorded under merged duplicate company entries are counted once.

Which registries list Concord/Portex's devices?

Among its 23 most recently registered devices, Concord/Portex has devices listed in FDA 510(k) (23 devices).

What risk classes do Concord/Portex's devices fall under?

Among its 23 most recently registered devices, the classes recorded for Concord/Portex's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Concord/Portex in the registry?

The most recently registered devices listed for Concord/Portex include SUCTION CONTROL VALVE, ACCU-VENT(TM) WITH NEEDLE-PRO(TM), NEEDLE-PRO CARTRIDGE and SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES.

Generated automatically from registry data and not verified by a human reviewer.