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Medicalyte(R) Bicarbonate Powder (36.83X), Medicalyte(R) Bicarbonate Powder (45X), Medicalyte(R) Bicarbonate Powder (35X

by Dialysis Medical Solutions, LLC

510(k) K131202

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131202 Date3 Apr 2014ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3134-2026 FDA Class II initiated 5 Aug 2026

    Hemodialysis concentrates contain high endotoxin levels

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  • Withdrawn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