Novalung ultimate kit (US)— 510(k) K232926

Name: FDA 510(k) clearance K232926
Creator: U.S. Food and Drug Administration
Published: 2024-04-15

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K232926 for Novalung ultimate kit (US), Substantially Equivalent on 2024-04-15. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.

Clearance details

Applicant: Fresenius Medical Care Renal Therapies Group, LLC
Product code: Code QJZ
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2023-09-20
Decision date: 2024-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJZ

view all

K261335 — VitalFlow Set with Balance Biosurface2026-07-31
K240880 — VitalFlow Set with Balance Biosurface2024-09-12
K191407 — Novalung System2020-02-21

More clearances from Fresenius Medical Care Renal Therapies Group, LLC

view all

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 QJZ

product code QJZ

Death: 22
Total: 22

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.