Skip to content

Hollow Fiber Dialyzers

by Terumo Medical Corp.

510(k) K820743

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 NumberK820743 Date23 Jun 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  • Withdrawn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, 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 Hollow Fiber Dialyzer is a capillary device designed for use in hemodialysis procedures. It functions by facilitating the exchange of solutes and water between blood and dialysate through a semipermeable membrane.

This device is classified as a Class II medical device under regulation number 876.5820 and product code FJI. It has received FDA 510(k) clearance for clinical use.

Other devices from Terumo Medical Corporation

See all devices from Terumo Medical Corporation →

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 primary function of the Hollow Fiber Dialyzer?

    This device is designed for use in hemodialysis procedures. It functions by facilitating the exchange of solutes and water between a patient's blood and the dialysate through a semipermeable membrane.

  • What is the regulatory status of this device?

    The Hollow Fiber Dialyzer is classified as a Class II medical device under regulation number 876.5820. It has received FDA 510(k) clearance for clinical use, indicating it is substantially equivalent to legally marketed predicate devices.

  • Which medical specialty is associated with this device?

    According to the device classification and review process, this product is categorized under the Gastroenterology and Urology medical specialties.