FDA applicant
Exo, Inc.
FDA records 5 decisions for Exo, Inc. (Santa Clara, CA) from 1983 to 2025: 5 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and FIQ (Cannula, A-V Shunt). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 151 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Exo, 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 Exo, 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