FDA applicant
CenterPoint Systems, LLC
FDA records 17 decisions for CenterPoint Systems, LLC (West Valley City, UT) from 2019 to 2026: 17 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Centerpoint Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided CenterPoint Systems, LLC’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like CenterPoint Systems, 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