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Kells Medical, Inc.

United StatesFDA applicant, unverified

Devices
12

What Kells Medical, Inc. makes

Kells Medical, Inc. manufactures single-use medical containers and transfer sets for enteral nutrition, including PVC empty solution containers with three-lead transfer sets, as well as specialized applicators for ear and nasal procedures. The company also produces skin closure devices like Dermizip and Dermidress, along with adhesive strips (Dermistrip) for wound management. Diagnostic tools in their portfolio include a phonatory function analyzer (PS-77) and an impedance meter (ON-1) for medical assessments, alongside a CPR feedback device (CPR Plus) and a doctor’s round stethoscope (SN-100).

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

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

Catalogue12

Newest first, rows 1-12 of 12

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  • Eva Empty Solution Container W/3 Lead Transfer Set Ref K890094

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

  • Lucae's Ear & Nasal Applicators Ref K832667

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

  • Pvc Empty Solution Container Enteral Pump Set Ref K890093

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

  • Say Ref K823118

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

  • Dermizip Skin Closure Device Ref K844072

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

  • Phonatory Function Analyzer Ps-77 Ref K832678

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

  • Cpr Plus Ref K926333

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

  • Dermidress Ref K844463

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

  • Impedance Meter On-1 Ref K823227

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

  • Sn-100 Doctor's Round Ref K823226

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

  • Dermistrip Ref K861972

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

  • Pvc Empty Solution Container W/3 Lead Transfer Set Ref K890095

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

Rows 1-12 of 12

Frequently asked questions

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

The registry currently lists 12 devices for Kells Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kells Medical, Inc.'s devices?

Among its 12 most recently registered devices, Kells Medical, Inc. has devices listed in FDA 510(k) (12 devices).

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

Among its 12 most recently registered devices, the classes recorded for Kells Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Kells Medical, Inc. include EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET, LUCAE'S EAR & NASAL APPLICATORS, PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET and SAY.

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