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Renaflo Hollow Fiber Dialyzer #100.1

by Renal Systems, Inc.

510(k) K801827

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 NumberK801827 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  • Withdrawn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.

The Renaflo Hollow Fiber Dialyzer #100.1 is a dialyzer, capillary, hollow fiber device classified as a Class II medical device. It is part of a hemodialysis system designed to function as an artificial kidney for treating patients with renal failure or toxemic conditions.

The device is supplied sterile and intended for single-use. It is MRI safe and available in size #100.1. The manufacturer, Renal Systems, Inc., holds FDA 510(k) clearance (K801827) for this product, which was reviewed by the Gastroenterology, Urology advisory committee.

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