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Infrasonics Corp.

United StatesFDA applicant, unverified

Devices
20

What Infrasonics Corp. makes

Infrasonics Corp. manufactures respiratory support devices, including ventilators for adults and infants, such as the Adult STAR, Infant STAR Series 500, and modifications of the STAR SYNC and STAR BREATHING CIRCUITS. Their portfolio also includes low-flow oxygen blenders like the OXY/STAR and medical suction devices, such as the HOYER SOLVET.

The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II medical devices. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

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

Catalogue20

Newest first, rows 1-20 of 20

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  • Star Sync, Modification Ref K913972

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

  • Star Breathing Circuits Ref K934753

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

  • Oxy/Star Low Flow Blender Ref K952878

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

  • Hoyer Solvet Ref K873395

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

  • Modified Star Calc Ref K895963

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

  • Star Sync Ref K884521

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

  • Infrasonics Ventilator Adult Star, Modification Ref K911804

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

  • Adult Ventilator Ref K943106

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

  • Ventilator Adult Star Modification Ref K922654

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

  • Adult Star Ref K872466

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

  • Infant Star Series 500 Ref K923704

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

  • Air Star Ref K920954

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

  • Accessory For Adult Vol. Ventilator Ref K842580

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

  • Adult Star, Modification Ref K905272

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

  • Star Calc Ref K875027

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

  • Transcutaneous Electronic Nerve Stimulator Ref K896825

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

  • Patient Breathing Circuit Ref K843036

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

  • Model 105 Ventilator, Modification Ref K922477

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

  • Patient Breathing Circuit Ref K853487

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

  • Infant Star Ventilator Ref K840865

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

Rows 1-20 of 20

Frequently asked questions

How many devices does Infrasonics Corp. have in the registry?

The registry currently lists 20 devices for Infrasonics Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Infrasonics Corp.'s devices?

Among its 20 most recently registered devices, Infrasonics Corp. has devices listed in FDA 510(k) (20 devices).

What risk classes do Infrasonics Corp.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Infrasonics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Infrasonics Corp. in the registry?

The most recently registered devices listed for Infrasonics Corp. include STAR SYNC, MODIFICATION, STAR BREATHING CIRCUITS, OXY/STAR LOW FLOW BLENDER and HOYER SOLVET.

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