FDA applicant
Tyto Care, Ltd.
FDA records 10 decisions for Tyto Care, Ltd. (Netanya, IL) from 2016 to 2026: 9 510(k) clearances and 1 De Novo grant. Most are in product codes PHZ (Abnormal Breath Sound Device) and DQD (Stethoscope, Electronic). Since 2016 its 510(k)s took a median of 216 days from receipt to decision, against 217 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 6 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 Tyto Care, Ltd.’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 2016.
Planning a device like Tyto Care, Ltd.’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