Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectrum Vascular — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
218 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-06-26 | 56 | 0 |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-03-25 | 85 | 0 |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Tec | Spectrum Vascular | 2025-12-16 | 139 | 0 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 | 142 | 0 |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Cent | Spectrum Vascular | 2024-11-27 | 218 | 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