Scientia Vascular, LLC: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Scientia Vascular, LLC” (first 2012, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 116 days, against 122 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 |
|---|---|---|
| 2012 | 1 | 47 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 212 |
| 2016 | 0 | — |
| 2017 | 1 | 67 |
| 2018 | 2 | 69 |
| 2019 | 2 | 58 |
| 2020 | 1 | 30 |
| 2021 | 1 | 58 |
| 2022 | 0 | — |
| 2023 | 5 | 265 |
| 2024 | 1 | 124 |
| 2025 | 1 | 102 |
| 2026 | 4 | 194 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scientia Vascular, LLC took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | 9 | 9 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| NRY | Catheter, Thrombus Retriever | 2 | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
- Neurology (13)
- Cardiovascular (7)
Most recent Scientia Vascular, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254181 | Aristotle 65 Macrowire | MOF | 2026-09-16 | 267 |
| K260223 | Aristotle Mini Guidewire | MOF | 2026-08-06 | 192 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | NRY | 2026-07-16 | 195 |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | MOF | 2026-04-29 | 163 |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | MOF | 2025-04-01 | 102 |
| K242301 | Socrates 38 Catheter | QJP | 2024-12-04 | 124 |
| K223913 | Socrates Aspiration System | NRY | 2023-09-20 | 265 |
| K223560 | Plato 17 Microcatheter | QJP | 2023-08-21 | 266 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | MOF | 2023-08-01 | 29 |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | MOF | 2023-03-10 | 392 |
10 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2025-01-16.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Scientia Cardio Access, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scientia Vascular, LLC?
FDA lists 20 510(k) clearances under the applicant name “Scientia Vascular, LLC” (first 2012, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scientia Vascular, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientia Vascular, LLC is 116 days. Since 2017: 116 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Scientia Vascular, LLC?
The most frequent FDA product codes under this applicant name are MOF (Guide, Wire, Catheter, Neurovasculature, 9); DQO (Catheter, Intravascular, Diagnostic, 3); DQX (Wire, Guide, Catheter, 3).
Next steps
- See all 20 Scientia Vascular, LLC clearances with predicates and recalls
- Run predicate analysis for product code MOF, Scientia Vascular, LLC'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.