510(k) Report

FDA applicant

Quara S.R.L.

Mirandola, IT1 decision2023–20232 recalls

FDA records 1 decision for Quara S.R.L. (Mirandola, IT) in 2023: 1 510(k) clearance. All are in product code DTR (Heat-Exchanger, Cardiopulmonary Bypass). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Quara S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

2in 2026

2026 (partial year): 2
2023high 2 (2026) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Quara S.R.L. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTRHeat-Exchanger, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L. · 20232 recalls

The one decision as Quara S.R.L. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K220110Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High…Jul 17, 2026Class II
  • K220110Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High…Jul 17, 2026Class II