AK 98 Dialysis Machine (955607)— 510(k) K250508

Name: FDA 510(k) clearance K250508
Creator: U.S. Food and Drug Administration
Published: 2025-08-01

Substantially Equivalent

Vantive US Healthcare, LLC

FDA 510(k) clearance K250508 for AK 98 Dialysis Machine (955607), Substantially Equivalent on 2025-08-01. Applicant: Vantive US Healthcare, LLC. Device class: 2.

Clearance details

Applicant: Vantive US Healthcare, LLC
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-21
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield Lake, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDI

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K261267 — Careflux H60; Careflux H70; Careflux V5002026-07-24
K252377 — NxStage System One with NxView2026-05-15
K260533 — ELISIO-H2026-03-19
K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)2026-02-10
K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)2026-01-26

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.