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Clirans Hollow Fiber Dialyzers

by Terumo Medical Corp.

510(k) K820524

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 NumberK820524 Date8 Jul 1982ClearedStatusActive

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  • Withdrawn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, 6 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 Clirans Hollow Fiber Dialyzers are a type of dialyzer, capillary, hollow fiber device. They are substantially equivalent and classified as a Class 2 device. The device is used in the medical specialty of Gastroenterology and Urology.

The Clirans Hollow Fiber Dialyzers are supplied with a product code of FJI and have an FDA 510K authorization. The device has a regulation number of 876.5820 and is registered with the FDA. The device is manufactured by Terumo Medical Corp. and has a k number of K820524.

Other devices from Terumo Medical Corporation

See all devices from Terumo Medical Corporation →

Questions

AI-generated answers, 6 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 Clirans Hollow Fiber Dialyzers used for?

    The Clirans Hollow Fiber Dialyzers are used in the medical specialty of Gastroenterology and Urology for dialysis.

  • What is the classification of the Clirans Hollow Fiber Dialyzers?

    The Clirans Hollow Fiber Dialyzers are classified as a Class 2 device.

  • What type of authorization does the Clirans Hollow Fiber Dialyzers have?

    The Clirans Hollow Fiber Dialyzers have an FDA 510K authorization.

  • What is the product code of the Clirans Hollow Fiber Dialyzers?

    The product code of the Clirans Hollow Fiber Dialyzers is FJI.