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Renaflo Hollow Fiber Dialyzers S.M.A.D.

by Renal Systems, Inc.

510(k) K801825

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 NumberK801825 Date26 Sep 1980ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

This device is a Dialyzer, Capillary, Hollow Fiber, as defined by its classification name. It is designed for use in hemodialysis to remove waste products and excess fluid from the blood.

It is supplied as a non-sterile, reusable device intended for use in clinical settings such as dialysis centers. The device has received FDA 510(k) clearance under K801825, is classified as Class II, and falls under regulation number 876.5820 with product code FJI. It is not MRI safe unless otherwise specified, and no sterility, single-use status, or storage conditions are provided in the data.

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Questions

AI-generated answers, 1 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 RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. used for?

    This device is designed for use in hemodialysis to remove waste products and excess fluid from the blood, as specified in its classification as a Dialyzer, Capillary, Hollow Fiber for clinical dialysis applications.

  • Is the RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. sterile or single-use?

    The device is supplied as non-sterile and reusable, intended for multiple uses in clinical settings such as dialysis centers, with no indication of sterility or single-use designation in the provided data.

  • How is the RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. supplied and what are its storage requirements?

    The device is supplied as a non-sterile, reusable unit for clinical use; however, no specific storage conditions are provided in the device data, so users should follow standard handling practices for non-sterile reusable medical equipment.