Product code KDI: 510(k) clearances and predicates
Product code KDI covers Careflux H60;Careflux H70;Careflux V500. FDA lists 345 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
345 clearances on file under product code KDI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 7 |
| 2024 | 7 |
| 2025 | 9 |
| 2026 so far | 5 |
Recent clearances
Newest KDI clearances in the FDA index, with applicant and decision date:
- K261267, Careflux H60;Careflux H70;Careflux V500, applicant Fresenius Medical Care Renal Therapies Group, LLC, decided 2026-07-24. FDA record
- K252377, NxStage System One with NxView, applicant Fresenius Medical Care Renal Therapies Group, LLC, decided 2026-05-15. FDA record
- K260533, ELISIO-H, applicant Nipro Medical Corporation, decided 2026-03-19. FDA record
- K252459, multiFlux 130 (F00013123); multiFlux 160 (F00013124), applicant Fresenius Medical Care Renal Therapies Group, LLC, decided 2026-02-10. FDA record
- K253412, Tablo Hemodialysis System (PN-0008000, PN-0006000U), applicant Outset Medical, Inc., decided 2026-01-26. FDA record
- K253518, FX CorAL 40; FX CorAL 50, applicant Fresenius Medical Care Renal Therapies Group, LLC, decided 2025-12-18. FDA record
- K243920, Purema H Hemoconcentrator - Pediatric, applicant Medica USA, Inc., decided 2025-09-19. FDA record
- K250508, AK 98 Dialysis Machine (955607), applicant Vantive US Healthcare, LLC, decided 2025-08-01. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include NxStage System One with NxView, ELISIO-H. Watch new KDI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code KDI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KDI clearances include Careflux H60;Careflux H70;Careflux V500.
How many 510(k) clearances use product code KDI?
345 at the time this page was generated, from openFDA records.
How do I find a predicate device under KDI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new KDI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.