FDA product code KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System
KDI is the FDA product code for dialyzer, high permeability with or without sealed dialysate system. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 345 510(k) submissions under KDI, 35 in the last five years, from 83 different applicants. The average 510(k) review took 176 days (median 125); 183 days on average over the last three years. FDA has posted 217 recalls for KDI devices, 63 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device class | Class II |
| Regulation | 21 CFR 876.5860 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for KDI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 200 |
| 2018 | 2 | 197 |
| 2019 | 4 | 226 |
| 2020 | 9 | 212 |
| 2021 | 2 | 206 |
| 2022 | 7 | 241 |
| 2023 | 7 | 169 |
| 2024 | 7 | 211 |
| 2025 | 9 | 192 |
| 2026 | 5 | 145 |
Compare with all 510(k) review times · Search every KDI clearance
Top KDI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nxstage Medical, Inc. | 26 | 2024-03-14 |
| Hospal Medical Corp. | 20 | 1989-07-24 |
| Fresenius Medical Care Renal Therapies Group, LLC | 19 | 2026-07-24 |
| Baxter Healthcare Corp | 18 | 2019-07-25 |
| Althin Medical AB an Affiliate of Baxter Intl | 18 | 1999-12-07 |
78 more applicants have KDI clearances. See the full list in Caduvo.
Most recent KDI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261267 | Fresenius Medical Care Renal Therapies Group, LLC | Careflux H60;Careflux H70;Careflux V500 | 2026-07-24 | 99 |
| K252377 | Fresenius Medical Care Renal Therapies Group, LLC | NxStage System One with NxView | 2026-05-15 | 289 |
| K260533 | Nipro Medical Corporation | ELISIO-H | 2026-03-19 | 30 |
| K252459 | Fresenius Medical Care Renal Therapies Group, LLC | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | 2026-02-10 | 189 |
| K253412 | Outset Medical, Inc. | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | 2026-01-26 | 118 |
Recalls for KDI devices
217 product recalls in 109 recall events; 63 initiated in the last five years and 67 still open. Most recent: 2026-06-30.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 9 |
| 2019 | 10 |
| 2020 | 10 |
| 2021 | 9 |
| 2022 | 18 |
| 2023 | 8 |
| 2024 | 21 |
| 2025 | 6 |
| 2026 | 9 |
Frequently asked questions
What is FDA product code KDI?
KDI is the FDA product code for dialyzer, high permeability with or without sealed dialysate system. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel.
What device class is KDI?
Class II, regulation 21 CFR 876.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDI?
Across 345 cleared submissions the average was 176 days from receipt to decision (median 125).
Which companies have the most KDI clearances?
Nxstage Medical, Inc. (26); Hospal Medical Corp. (20); Fresenius Medical Care Renal Therapies Group, LLC (19); Baxter Healthcare Corp (18); Althin Medical AB an Affiliate of Baxter Intl (18).
Have KDI devices been recalled?
Yes: 217 product recalls across 109 recall events; the most recent began 2026-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KDI
- Run a recall and safety report across every KDI manufacturer
- Watch product code KDI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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