510(k) Report

FDA applicant

Home Dialysis Plus

Sunnyvale, CA2 decisions2014–20140 recalls

FDA records 2 decisions for Home Dialysis Plus (Sunnyvale, CA) in 2014: 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 3 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 Home Dialysis Plus’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014: 2
2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Home Dialysis Plus by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140866Tablo ConsoleHome Dialysis Plus · 20142cite it
  • K140841Tablo CartridgeHome Dialysis Plus · 20142cite it

What has FDA decided for it lately?

  • K140841Tablo CartridgeHome Dialysis Plus · 2014
  • K140866Tablo ConsoleHome Dialysis Plus · 2014

All 2 as Home Dialysis Plus →