FDA applicant
Ihealth Labs, Inc.
FDA records 4 decisions for Ihealth Labs, Inc. (Sunnyvale, CA) from 2024 to 2025: 4 510(k) clearances. Most are in product codes SCA (Multi-Analyte Respiratory Virus Antigen…) and QYT (Over-The-Counter Covid-19 Antigen Test). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 148 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 Ihealth Labs, 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 2024.
Planning a device like Ihealth Labs, 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