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FDA product code · Gastroenterology, Urology · Class 2

KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

KPO is FDA's product code for "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)": a Class 2 device classified under 21 CFR 876.5820, reviewed by the Gastroenterology, Urology panel. FDA flags it as life-sustaining or life-supporting.

510(k) review time for KPO

Across 20 510(k) clearances under KPO decided from 2018-01-01 to 2026-10-06, the median was 264 days from FDA receipt to decision. Half took between 114 and 268 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, KPO, decisions 2018-01-01 to 2026-10-06 (n = 20)
Fastest23
25th percentile114
Median264
75th percentile268
80th percentile269
90th percentile283
Slowest711

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

KPO in the public FDA record

Records naming KPO, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years124
Device recalls113
Establishment listings102
GUDID device identifiers678

Counts of records, not of devices or events. Adverse event reports for KPO are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite KPO

8 FDA recognized consensus standards cite KPO, 4 of them recognized only in part, among them ISO 23500-1 First edition 2019-02; ISO 23500-3 First edition 2019-02; ISO 23500-4 First edition 2019-02. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 9-133 ISO 23500-1 First edition 2019-02 (partial recognition) — Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
  • 9-135 ISO 23500-3 First edition 2019-02 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
  • 9-136 ISO 23500-4 First edition 2019-02 (partial recognition) — Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
  • 9-137 ISO 23500-5 First edition 2019-02 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
  • 9-152 ISO 23500-1 Second edition 2024-08 (partial recognition) — Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
  • 9-154 ISO 23500-3 Second edition 2024-04 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
  • 9-155 ISO 23500-4 Second edition 2024-04 (partial recognition) — Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
  • 9-156 ISO 23500-5 Second edition 2024-04 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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