Skip to content

GC-1000 Through GC-3005 Acid Concentrate

by Granite Chemical Co., Inc.

510(k) K901471

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 NumberK901471 Date27 Jul 1990ClearedStatusActive

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  • Withdrawn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
KPO
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 GC-1000 Through GC-3005 Acid Concentrate is a dialysate concentrate for hemodialysis, available in liquid or powder form. This device is used in hemodialysis procedures to help remove waste and excess fluid from the blood.

The device is supplied as an acid concentrate and is regulated under FDA 510(k) clearance with product code KPO. It is manufactured by Granite Chemical Co., Inc. and is intended for use in gastroenterology and urology settings. The device is classified as Class II and is not specified as single-use or reusable in the provided data.

Other devices from Granite Chemical Co., Inc.