510(k) Report

FDA applicant

Diality, Inc.

Irvine, CA2 decisions2024–20240 recalls

FDA records 2 decisions for Diality, Inc. (Irvine, CA) in 2024: 2 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJK (Set, Tubing, Blood, With And Without…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Diality, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024: 2
2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Diality, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Diality, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc. · 2024
  • K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc. · 2024

All 2 as Diality, Inc. →