Optiflux dialyzer

• • Ongoing Z-0041-2026 FDA Class II ·initiated 29 Aug 2025 ·on shared 510(k) K162488

  To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

• • Ongoing Z-0801-2025 FDA Class II ·initiated 5 Dec 2024

  Potential for internal blood leaks due to cracked polyurethane

• • Terminated Z-1303-2022 FDA Class II ·initiated 4 May 2022

  Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

• • Terminated Z-0658-2019 FDA Class II ·initiated 5 Nov 2018

  Potential for external blood leaks from the dialyzer header

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K162488 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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