FDA applicant
Visby Medical, Inc.
FDA records 6 decisions for Visby Medical, Inc. (San Jose, CA) from 2021 to 2026: 5 510(k) clearances and 1 De Novo grant. Most are in product codes QEP (Nucleic Acid Detection System For Non-Viral…) and SEA (Test For Detection Of Microorganism (S)…). Since 2016 its 510(k)s took a median of 282 days from receipt to decision, against 297 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Visby Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Visby Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Visby Medical, 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