Qura S.R.L: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Qura S.R.L” (first 2020, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 193 days. Since 2017 the median was 193 days, against 123 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 112 |
| 2021 | 4 | 394 |
| 2022 | 5 | 138 |
| 2023 | 3 | 145 |
| 2024 | 1 | 435 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Qura S.R.L took a median 193 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 5 | 5 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 4 | 4 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 4 | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 2 | 2 |
Review panels
- Cardiovascular (15)
Most recent Qura S.R.L 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | DTZ | 2024-09-12 | 435 |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | DTZ | 2023-11-08 | 145 |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | KFM | 2023-10-26 | 30 |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | KFM | 2023-05-19 | 422 |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS | DWF | 2022-08-18 | 100 |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | DWF | 2022-05-20 | 193 |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | DTR | 2022-05-06 | 113 |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | DTZ | 2022-01-28 | 184 |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | DTR | 2022-01-10 | 138 |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | DTZ | 2021-12-17 | 392 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-03-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Qura S.R.L?
FDA lists 15 510(k) clearances under the applicant name “Qura S.R.L” (first 2020, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Qura S.R.L?
The median time from FDA receipt to decision across 510(k)s cleared under the name Qura S.R.L is 193 days. Since 2017: 193 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Qura S.R.L?
The most frequent FDA product codes under this applicant name are KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 5); DTZ (Oxygenator, Cardiopulmonary Bypass, 4); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 4).
Next steps
- See all 15 Qura S.R.L clearances with predicates and recalls
- Run predicate analysis for product code KFM, Qura S.R.L's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.