Transit Scientific, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Transit Scientific, LLC” (first 2020, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 161 days. Since 2017 the median was 161 days, against 108 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 |
|---|---|---|
| 2020 | 2 | 156 |
| 2021 | 1 | 259 |
| 2022 | 2 | 104 |
| 2023 | 1 | 161 |
| 2024 | 1 | 322 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Transit Scientific, LLC took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 3 | 3 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 3 | 3 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Transit Scientific, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | PNO | 2024-06-17 | 322 |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | KRA | 2023-11-29 | 161 |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | PNO | 2022-10-18 | 104 |
| K214107 | XO CROSS CORONARY Support Catheter | DQY | 2022-04-11 | 103 |
| K210322 | XO Cross Support Catheter | DQY | 2021-10-21 | 259 |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | PNO | 2020-05-29 | 164 |
| K193420 | XO Cross Support Catheter | DQY | 2020-05-06 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Transit Scientific, LLC.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Transit Scientific, LLC?
FDA lists 7 510(k) clearances under the applicant name “Transit Scientific, LLC” (first 2020, latest 2024), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Transit Scientific, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transit Scientific, LLC is 161 days. Since 2017: 161 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Transit Scientific, LLC?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 3); PNO (Catheter, Percutaneous, Cutting/Scoring, 3); KRA (Catheter, Continuous Flush, 1).
Next steps
- See all 7 Transit Scientific, LLC clearances with predicates and recalls
- Run predicate analysis for product code DQY, Transit Scientific, 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.