Spectrum Medical S.R.L.: FDA clearances and approvals
Spectrum Medical S.R.L. has 6 FDA 510(k) clearances (first 2024, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time: 109 days. Since 2017 its median was 109 days, against 123 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 2 | 54 |
| 2025 | 2 | 98 |
| 2026 | 2 | 459 |
Review time against the same product codes
Since 2017, Spectrum Medical S.R.L.'s cleared 510(k)s took a median 109 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 | 2 | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Spectrum Medical S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | DTR | 2026-03-12 | 212 |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | DTZ | 2026-03-12 | 706 |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | KFM | 2025-08-04 | 56 |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | KFM | 2025-06-24 | 139 |
| K241206 | Quantum Perfusion Hybrid System | DTN | 2024-07-18 | 79 |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | DWF | 2024-05-31 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Spectrum Medical S.R.L..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Spectrum Medical S.R.L. have?
Spectrum Medical S.R.L. has 6 FDA 510(k) clearances (first 2024, latest 2026), across 5 product codes in 1 review panel.
How long does FDA take to clear Spectrum Medical S.R.L.'s 510(k)s?
The median time from FDA receipt to decision across Spectrum Medical S.R.L.'s cleared 510(k)s is 109 days. Since 2017: 109 days, versus 123 days for all cleared 510(k)s in the same product codes.
What devices does Spectrum Medical S.R.L. make?
Its most frequent FDA product codes are KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 2); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 1); DTR (Heat-Exchanger, Cardiopulmonary Bypass, 1).
Has Spectrum Medical S.R.L. had device recalls?
openFDA lists no recalls under a recalling firm name matching Spectrum Medical S.R.L. Related entities may recall under other names.
Next steps
- See all 6 Spectrum Medical S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code KFM, Spectrum Medical S.R.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.