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NxStage Premixed Dialysate

by NxStage Medical, Inc.

510(k) K022913

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

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022913 Date21 Oct 2002ClearedStatusActive

Official records

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  • Withdrawn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, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

NxStage Premixed Dialysate is a dialysate concentrate for hemodialysis (liquid or powder) used in the treatment of kidney failure. It is a premixed solution formulated for use in home hemodialysis systems.

The device is supplied as a liquid concentrate in bags and is intended for single-use in home hemodialysis settings. It has received FDA 510(k) clearance (K022913) and is classified as a Class II medical device under regulation number 876.5820.

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