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Renal Devices, Inc.

United StatesFDA applicant, unverified

Devices
4

What Renal Devices, Inc. makes

Renal Devices, Inc. manufactures hemodialysis equipment, specifically hollow fiber dialyzers and their associated holders, including the Hemophron and RDI-1 models.

These Class II medical devices are based in the United States and are listed in the FDA 510(k) regulatory registry.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Hemophron Ref K810612

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Hollo Fiber Dialyzer Ref K801559

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Hollow Fiber Dialyzer Holder Ref K802075

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Rdi-1 Hollow Fiber Dialyzer Ref K790696

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

Frequently asked questions

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

The registry currently lists 4 devices for Renal Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Renal Devices, Inc.'s devices?

Among its 4 most recently registered devices, Renal Devices, Inc. has devices listed in FDA 510(k) (4 devices).

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

Among its 4 most recently registered devices, the classes recorded for Renal Devices, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Renal Devices, Inc. include HEMOPHRON, HOLLO FIBER DIALYZER, HOLLOW FIBER DIALYZER HOLDER and RDI-1 HOLLOW FIBER DIALYZER.

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