FDA applicant
Transit Scientific, LLC
FDA records 7 decisions for Transit Scientific, LLC (Salt Lake City, UT) from 2020 to 2024: 7 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and PNO (Catheter, Percutaneous, Cutting/Scoring). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Transit Scientific”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Transit Scientific, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Transit Scientific, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report