FDA product code · Gastroenterology, Urology · Class 2
KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System
KDI is FDA's product code for "Dialyzer, High Permeability With Or Without Sealed Dialysate System": a Class 2 device classified under 21 CFR 876.5860, reviewed by the Gastroenterology, Urology panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for KDI
Across 52 510(k) clearances under KDI decided from 2018-01-01 to 2026-10-06, the median was 216 days from FDA receipt to decision. Half took between 112 and 266 days, and 80% were decided within 272 days. These are past clearances, not a forecast for a new submission.
| Fastest | 8 |
|---|---|
| 25th percentile | 112 |
| Median | 216 |
| 75th percentile | 266 |
| 80th percentile | 272 |
| 90th percentile | 317 |
| Slowest | 451 |
| Year | Median days | n |
|---|---|---|
| 2020 | 266 | 9 |
| 2022 | 259 | 7 |
| 2023 | 157 | 7 |
| 2024 | 235 | 7 |
| 2025 | 199 | 9 |
| 2026 (to 10-06, partial) | 118 | 5 |
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.
KDI in the public FDA record
| 510(k) clearances, all years | 345 |
|---|---|
| Device recalls | 217 |
| Establishment listings | 274 |
Counts of records, not of devices or events. Adverse event reports for KDI 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 KDI
2 FDA recognized consensus standards cite KDI, 1 of them recognized only in part, among them ISO 8637-1 First edition 2017-11; IEC 60601-2-16 Edition 5.0 2018-4. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 9-118 ISO 8637-1 First edition 2017-11 (partial recognition) — Extracorporeal systems for blood purification -- Part 1: Haemodialysers haemodiafilters haemofilters and haemoconcentrators
- 9-121 IEC 60601-2-16 Edition 5.0 2018-4 — Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis haemodiafiltration and haemonfiltration equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.