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Modified Biologic 1000 Hemodial. & Hd-1000 Dis Car

by Ash Medical Systems, Inc.

510(k) K874137

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 NumberK874137 Date8 Apr 1988ClearedStatusActive

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  • Withdrawn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
FKT
Device Class
Class II
Regulation
21 CFR Part 876.5600
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Modified Biologic 1000 Hemodialysis and HD-1000 Disposable Cartridge is a sorbent regenerated dialysate delivery system. It is designed to facilitate the delivery of dialysate during hemodialysis procedures.

This device is regulated under FDA 510(k) clearance K874137 and is classified as a Class 2 medical device under regulation number 876.5600. It is manufactured by Ash Medical Systems, Inc. and is categorized under the Gastroenterology and Urology medical specialty.

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