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Calbio, Inc.

United StatesFDA applicant, unverified

Devices
2

What Calbio, Inc. makes

Calbio, Inc. manufactures a pressure infusion pump for controlled medication delivery and an intubation kit for airway management procedures.

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

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

Catalogue2

Newest first, rows 1-2 of 2

  • Pressure Infusion Pump Ref K813105

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Intubation Kit Ref K832629

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

Frequently asked questions

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

The registry currently lists 2 devices for Calbio, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Calbio, Inc.'s devices?

Among its 2 most recently registered devices, Calbio, Inc. has devices listed in FDA 510(k) (2 devices).

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

Among its 2 most recently registered devices, the classes recorded for Calbio, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Calbio, Inc. include PRESSURE INFUSION PUMP and INTUBATION KIT.

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