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APS Series Dialyzers

by Asahi Medical Co., Ltd.

510(k) K001250

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK001250 Date16 Aug 2000ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0790-05 FDA Unclassified (pre-2012) initiated 31 Mar 2005

    Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

    • Terminated Z-0739-04 FDA Unclassified (pre-2012) initiated 1 Oct 2001

    Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)
510(k) Number
FDA Product Code
KDI
Device Class
Class II
Regulation
21 CFR Part 876.5860
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 APS Series Dialyzers are high permeability devices designed for use in dialysis procedures. These units function as a dialyzer with or without a sealed dialysate system to facilitate solute removal.

This device is available in both wet and dry models and is regulated as a Class II medical device. It has received FDA 510(k) clearance under the product code KDI.

Other devices from Asahi Medical Co., Ltd.

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Questions

AI-generated answers, 25 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 APS Series Dialyzers?

    These devices are high permeability dialyzers designed to facilitate solute removal during dialysis procedures. They are engineered to function effectively with or without a sealed dialysate system.

  • Are there different versions of the APS Series Dialyzers available?

    Yes, the APS Series is available in both wet and dry models to accommodate different clinical requirements and setup preferences for dialysis.

  • What is the regulatory classification of this device?

    The APS Series Dialyzers are regulated as Class II medical devices and have received FDA 510(k) clearance under product code KDI.