FDA applicant
Vioptix, Inc.
FDA records 9 decisions for Vioptix, Inc. (Newark, CA) from 2005 to 2025: 9 510(k) clearances. Most are in product codes MUD (Oximeter, Tissue Saturation) and MVR (Device, Anastomotic, Microvascular). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vioptix, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vioptix, Inc.’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