Skip to content

Bio*Nephross I.Q. Andante

by Organon Teknika Corp. 510(k)

Active United States

510(k) K882339

Overview

The device is a Dialyzer, Capillary, Hollow Fiber, classified under medical specialty Gastroenterology and Urology. It is a Class 2 medical device identified by the product code FJI and clearance number K882339.

It was cleared via the Traditional 510(k) pathway by the FDA on June 28, 1988, following submission on June 6, 1988. The device is manufactured by Organon Teknika Corp. and is substantially equivalent to a legally marketed predicate device.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882339 Date28 Jun 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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

Other devices from Organon Teknika Corp.

See all devices from Organon Teknika Corp. →

Questions

  • What is the BIO*NEPHROSS I.Q. ANDANTE device used for?

    The BIO*NEPHROSS I.Q. ANDANTE is a capillary hollow fiber dialyzer designed for use in gastroenterology and urology medical specialties, as indicated by its product code FJI and classification under those specialties in the FDA clearance documentation.

  • How was the BIO*NEPHROSS I.Q. ANDANTE cleared for market release?

    The device received FDA clearance through the Traditional 510(k) pathway on June 28, 1988, after submission on June 6, 1988, based on a determination of substantial equivalence to a legally marketed predicate device under product code FJI.

  • What regulatory classification and identifiers apply to the BIO*NEPHROSS I.Q. ANDANTE?

    It is classified as a Class 2 medical device with product code FJI, clearance number K882339, and is associated with regulation number 876.5820, FEI number 1721676, and registration numbers including 2028411 and 1721676 as listed in the openFDA data.