Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transit Scientific, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
322 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constrai | Transit Scientific, LLC | 2024-06-17 | 322 | 0 |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20- | Transit Scientific, LLC | 2023-11-29 | 161 | 0 |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Ca | Transit Scientific, LLC | 2022-10-18 | 104 | 0 |
| K214107 | XO CROSS CORONARY Support Catheter | Transit Scientific, LLC | 2022-04-11 | 103 | 0 |
| K210322 | XO Cross Support Catheter | Transit Scientific, LLC | 2021-10-21 | 259 | 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