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Blood Tubing

by Renal Systems, Inc.

510(k) K834596

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834596 Date4 Feb 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KOC
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Blood tubing is an accessory component of the hemodialysis blood circuit, used to transport blood between the patient and the dialysis machine. It is classified under the FDA device category "Accessories, Blood Circuit, Hemodialysis" and is identified by product code KOC.

The device is marketed by Renal Systems, Inc. of Mchenry, Illinois, and received FDA 510(k) clearance (K834596) on February 4, 1984 as a Class II device with special controls. The clearance indicates the product is substantially equivalent to a predicate device, and it is listed under the regulatory number 876.5820.

Other devices from Renal Systems, Inc.

See all devices from Renal Systems, Inc. →

Questions

AI-generated answers, 22 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 purpose of blood tubing in hemodialysis?

    Blood tubing is an accessory component of the hemodialysis blood circuit, specifically designed to transport blood between the patient and the dialysis machine during treatment.

  • What is the regulatory status of this blood tubing product?

    The blood tubing received FDA 510(k) clearance (K834596) on February 4, 1984 as a Class II device with special controls, indicating it is substantially equivalent to a predicate device.

  • How is the blood tubing supplied and what are its specifications?

    The device is classified under the FDA device category 'Accessories, Blood Circuit, Hemodialysis' and is identified by product code KOC. It is manufactured by Renal Systems, Inc. of Mchenry, Illinois.

  • Is this blood tubing single-use or reusable?

    The device data does not specify whether the blood tubing is designed for single-use or multiple uses. This information would be detailed in the product's instructions for use provided by the manufacturer.