FDA applicant
Balt USA, LLC
FDA records 20 decisions for Balt USA, LLC (Irvine, CA) from 2018 to 2026: 19 510(k) clearances and 1 original PMA approval. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and HCG (Device, Neurovascular Embolization). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 8 of them its own earlier devices. 6 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Balt USA, LLC’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Balt USA, 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