510(k) Report

FDA applicant

Qura S.R.L

Mirandola, IT15 decisions2020–20243 recalls

FDA records 15 decisions for Qura S.R.L (Mirandola, IT) from 2020 to 2024: 15 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and DTZ (Oxygenator, Cardiopulmonary Bypass). Since 2016 its 510(k)s took a median of 329 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 of them its own earlier devices. 3 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 Qura S.R.L’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 22021: 42022: 52023: 32024: 1
2020high 5 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

2in 2026

2025: 12026 (partial year): 2
2020high 2 (2026) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Qura S.R.L by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type5decisions
  • DTZOxygenator, Cardiopulmonary Bypass4decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass4decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass2decisions

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 329 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 135 days; 1 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L · 20212cite it
  • K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 20221cites it
  • K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum…Qura S.R.L · 20211cites it
  • K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood…Qura S.R.L · 20231cites it
  • K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual…Qura S.R.L · 20221cites it
  • K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual…Qura S.R.L · 20211cites it

What has FDA decided for it lately?

  • K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L · 2024
  • K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood…Qura S.R.L · 2023
  • K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion…Qura S.R.L · 2023
  • K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood…Qura S.R.L · 2023
  • K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual…Qura S.R.L · 2022
  • K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022
  • K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 20222 recalls
  • K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood…Qura S.R.L · 2022

All 15 as Qura S.R.L →

What has been recalled?

3 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
  • K201320Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors…Jan 16, 2025Class II