Hemodialysis Tubing Sets

by Ofi Biomedica S.P.A.

510(k) K001971

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

510(k) K001971↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK001971	Date24 May 2001Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K001971
FDA Product Code: FIB

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

Overview

AI-generated summary, 21 Sep 2026

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

Hemodialysis tubing sets are components of a hemodialysis system used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions. These sets form part of the extracorporeal blood system that facilitates blood flow during dialysis procedures.

The device is supplied as a tubing set and is classified under product code FIB with FDA 510(k) clearance. It is intended for use in hemodialysis procedures and is regulated under the FDA as a class II device. The device is manufactured by Ofi Biomedica S.P.A. and has the model number K001971.