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Promedic, Inc.

United StatesFDA applicant, unverified

Devices
16

What Promedic, Inc. makes

Promedic, Inc. manufactures medical devices for neonatal and pediatric care, including respiratory support tools like the BABYAIR and DATEX ENGSTROM manual resuscitator, as well as feeding solutions such as infant feeding tubes, pediatric feeding tubes, and non-IV adapters for infant nasogastric tubes. The company also produces urinary catheters, fenestrated infusion catheters, and disposable respiratory face masks for anesthesia and ventilation. Additional products include urinary drainage accessories like CLEARPATH 24 and a pressurizer for medical gas delivery.

The company’s devices are regulated under FDA Class I and Class II classifications, with many authorised through the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Babyair Ref K060497

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

  • Non-Iv Adapter For Infant Ng Tube Ref K072756

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

  • Infant Feeding Tubes Ref K020005

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

  • Burlew Infant Hood Ref K962182

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

  • Fenestrated Infusion Catheter Ref K024190

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

  • Clearpath 24 Ref K112318

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

  • Urinary Catheters Ref K031409

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

  • Datex Engstom Manual Resuscitator Ref K970991

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

  • Pediatric Feeding Tube Ref K052903

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

  • Pressurizer Ref K951988

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

  • Air-Soft-Disposable, Anesthesisa/Respiratory Face Mask Ref K951043

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

  • Filter Ref K970102

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

  • Revjet Turbo Ref K060842

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

  • Buonafede Pneumatic Sleeve Ref K954201

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

  • Gas Sampling Lines Ref K023579

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

  • Eum 100PRO Ref K131889

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

Rows 1-16 of 16

Frequently asked questions

How many devices does Promedic, Inc. have in the registry?

The registry currently lists 16 devices for Promedic, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Promedic, Inc.'s devices?

Among its 16 most recently registered devices, Promedic, Inc. has devices listed in FDA 510(k) (16 devices).

What risk classes do Promedic, Inc.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Promedic, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Promedic, Inc. in the registry?

The most recently registered devices listed for Promedic, Inc. include BABYAIR, NON-IV ADAPTER FOR INFANT NG TUBE, INFANT FEEDING TUBES and BURLEW INFANT HOOD.

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