Spectrum Vascular: FDA clearances and approvals
Spectrum Vascular has 6 FDA 510(k) clearances (first 2024, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time: 140 days. Since 2017 its median was 140 days, against 148 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 218 |
| 2025 | 2 | 140 |
| 2026 | 3 | 85 |
Review time against the same product codes
Since 2017, Spectrum Vascular's cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Review panels
- General Hospital (4)
- Cardiovascular (2)
Most recent Spectrum Vascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260165 | Unimpregnated Central Venous Catheter | FOZ | 2026-08-10 | 202 |
| K261455 | Arterial Pressure Monitoring Set/Tray | DQO | 2026-06-26 | 56 |
| K254278 | Arterial Pressure Monitoring Set/Tray | DQO | 2026-03-25 | 85 |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | LJS | 2025-12-16 | 139 |
| K250724 | Intraosseous Infusion Needles | FMI | 2025-07-30 | 142 |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | FOZ | 2024-11-27 | 218 |
Recalls
openFDA lists no recalls under a recalling firm named Spectrum Vascular.
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 Vascular have?
Spectrum Vascular has 6 FDA 510(k) clearances (first 2024, latest 2026), across 4 product codes in 2 review panels.
How long does FDA take to clear Spectrum Vascular's 510(k)s?
The median time from FDA receipt to decision across Spectrum Vascular's cleared 510(k)s is 140 days. Since 2017: 140 days, versus 148 days for all cleared 510(k)s in the same product codes.
What devices does Spectrum Vascular make?
Its most frequent FDA product codes are DQO (Catheter, Intravascular, Diagnostic, 2); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Has Spectrum Vascular had device recalls?
openFDA lists no recalls under a recalling firm name matching Spectrum Vascular. Related entities may recall under other names.
Next steps
- See all 6 Spectrum Vascular clearances with predicates and recalls
- Run predicate analysis for product code DQO, Spectrum Vascular'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.