Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectrum Medical S.R.L. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
706 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); | Spectrum Medical S.R.L. | 2026-03-12 | 706 | 0 |
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026-03-12 | 212 | 0 |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integra | Spectrum Medical S.R.L. | 2025-08-04 | 56 | 0 |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integra | Spectrum Medical S.R.L. | 2025-06-24 | 139 | 0 |
| K241206 | Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. | 2024-07-18 | 79 | 0 |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | 2024-05-31 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda