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FDA product code · Gastroenterology, Urology · Class 2

FIP: Subsystem, Water Purification

FIP is FDA's product code for "Subsystem, Water Purification": a Class 2 device classified under 21 CFR 876.5665, reviewed by the Gastroenterology, Urology panel.

510(k) review time for FIP

Across 14 510(k) clearances under FIP decided from 2018-01-01 to 2026-10-06, the median was 124 days from FDA receipt to decision. Half took between 61 and 267 days, and 80% were decided within 267 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FIP, decisions 2018-01-01 to 2026-10-06 (n = 14)
Fastest24
25th percentile61
Median124
75th percentile267
80th percentile267
90th percentile269
Slowest271

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.

FIP in the public FDA record

Records naming FIP, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years117
Device recalls15
Establishment listings154
GUDID device identifiers898

Counts of records, not of devices or events. Adverse event reports for FIP 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 FIP

8 FDA recognized consensus standards cite FIP, 2 of them recognized only in part, among them ISO 23500-1 First edition 2019-02; ISO 23500-2 First edition 2019-02; ISO 23500-3 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
  • 9-134 ISO 23500-2 First edition 2019-02 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
  • 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
  • 9-137 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
  • 9-153 ISO 23500-2 Second edition 2024-07 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
  • 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
  • 9-156 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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