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DRS 4 ND Dialyzer Reprocessing System

by Seratronics, Inc.

510(k) K944539

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 NumberK944539 Date29 Nov 1995ClearedStatusActive

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  • Withdrawn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
LIF
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The DRS 4 ND Dialyzer Reprocessing System is a device used for reprocessing dialyzers. It is designed to clean and prepare dialyzers for reuse in hemodialysis procedures.

This device is manufactured by Seratronics, Inc. and is intended for single-use or reuse as specified in its reprocessing protocol. It is regulated under FDA 510(k) clearance with product code LIF and is used in gastroenterology and urology settings.

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Questions

AI-generated answers, 27 Sep 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 DRS 4 ND Dialyzer Reprocessing System used for?

    The DRS 4 ND Dialyzer Reprocessing System is designed to clean and prepare dialyzers for reuse in hemodialysis procedures, ensuring proper sterilization and functionality for subsequent patient treatments.

  • Is the DRS 4 ND Dialyzer Reprocessing System single-use or reusable?

    The DRS 4 ND Dialyzer Reprocessing System can be used for either single-use or reuse as specified in its reprocessing protocol, depending on the facility's protocols and regulatory guidelines.

  • What regulatory approvals does the DRS 4 ND Dialyzer Reprocessing System have?

    The DRS 4 ND Dialyzer Reprocessing System is regulated under FDA 510(k) clearance with product code LIF and is used in gastroenterology and urology settings, as indicated by its regulatory classification.

  • What are the specifications of the DRS 4 ND Dialyzer Reprocessing System?

    The DRS 4 ND Dialyzer Reprocessing System is manufactured by Seratronics, Inc. and has received FDA clearance as substantially equivalent, with its primary use being in the reprocessing of dialyzers for hemodialysis procedures.