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RDI-1 Hollow Fiber Dialyzer

by Renal Devices, Inc.

510(k) K790696

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790696 Date20 Jun 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FJI
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A dialyzer, capillary, hollow fiber is a device used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions. It consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories, where blood flows through tubing to the dialyzer for solute and fluid removal.

The RDI-1 Hollow Fiber Dialyzer (K790696) received FDA 510(k) clearance on June 20, 1979, under product code FJI and device class II. It is manufactured by Renal Devices, Inc. and is substantially equivalent to a legally marketed predicate device.

Other devices from Renal Devices, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RDI-1 Hollow Fiber Dialyzer used for?

    The RDI-1 Hollow Fiber Dialyzer is used as part of an artificial kidney system to remove solutes and fluids from blood in patients with renal failure or toxemic conditions, where blood flows through tubing to the dialyzer for treatment.

  • How is the RDI-1 Hollow Fiber Dialyzer supplied and is it reusable?

    The device data does not specify supply format or reusability; as a hollow fiber dialyzer, it is typically designed for single-use in extracorporeal circuits, but reuse protocols would depend on manufacturer instructions and clinical guidelines not provided here.

  • What regulatory pathway cleared the RDI-1 Hollow Fiber Dialyzer?

    The RDI-1 Hollow Fiber Dialyzer (K790696) received FDA 510(k) clearance via the traditional pathway on June 20, 1979, based on substantial equivalence to a predicate device under product code FJI and device class II.