510(k) Report

FDA applicant

Haemopharm Biofluids S.R.L.

Tovo Di S. Agata, IT2 decisions2015–20210 recalls

FDA records 2 decisions for Haemopharm Biofluids S.R.L. (Tovo Di S. Agata, IT) from 2015 to 2021: 2 510(k) clearances. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 2 predicates, 1 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 Haemopharm Biofluids S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015: 12021: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Haemopharm Biofluids S.R.L. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150966HMB32Haemopharm Biofluids S.R.L. · 20151cites it

What has FDA decided for it lately?

  • K212052HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L. · 2021
  • K150966HMB32Haemopharm Biofluids S.R.L. · 2015

All 2 as Haemopharm Biofluids S.R.L. →