AquaC UNO H— 510(k) K250471

Name: FDA 510(k) clearance K250471
Creator: U.S. Food and Drug Administration
Published: 2025-11-14

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K250471 for AquaC UNO H, Substantially Equivalent on 2025-11-14. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.

Clearance details

Applicant: Fresenius Medical Care Renal Therapies Group, LLC
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-18
Decision date: 2025-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIP

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K251851 — DIASAFEplusUS (F00013010)2025-10-09
K252181 — AquaA2025-09-09
K250514 — UPT Series Medical RO Water Treatment System2025-03-17
K232953 — AquaBplus; AquaB LITE2024-06-13
K223479 — AQUAbase nX2023-08-16

More clearances from Fresenius Medical Care Renal Therapies Group, LLC

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K261267 — Careflux H60; Careflux H70; Careflux V5002026-07-24
K252377 — NxStage System One with NxView2026-05-15
K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)2026-02-10
K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)2026-01-29
K253518 — FX CorAL 40; FX CorAL 502025-12-18

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.