FDA applicant
Omron Healthcare, Inc.
FDA records 69 decisions for Omron Healthcare, Inc. (Bonita Springs, FL) from 1991 to 2026: 68 510(k) clearances and 1 De Novo grant. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and CAF (Nebulizer (Direct Patient Interface)). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 35 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “OMRON Healthcare, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Omron Healthcare, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Omron Healthcare, 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) ReportOther applicant names beginning “Omron”
FDA records each applicant name separately; these may or may not be the same firm.