Company ยท IL
Tyto Care , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2026 | K252844 | Tyto Insights for Wheeze Detection (with PCCP) Tyto Care , Ltd., IL | PHZ |
| Mar 17, 2026 | DEN250014 | Tyto Insights for Eardrum Bulging Detection Tyto Care , Ltd., IL | SHL |
| Mar 12, 2026 | K252089 | Tyto Stethoscope (G3) Tyto Care , Ltd., IL | DQD |
| Apr 7, 2025 | K243567 | Tyto Insights for Rhonchi Detection Tyto Care , Ltd., IL | PHZ |
| Jul 2, 2024 | K240555 | Tyto Insights for Crackles Detection Tyto Care , Ltd., IL | PHZ |
| Dec 13, 2023 | K232237 | Tyto Insights for Wheeze Detection Tyto Care , Ltd., IL | PHZ |
| Feb 24, 2023 | K221614 | TytoCare Lung Sounds Analyzer Tyto Care , Ltd., IL | PHZ |
| Mar 27, 2019 | K190242 | Tyto Thermometer Tyto Care , Ltd., IL | FLL |
| Dec 17, 2018 | K181612 | Tyto Stethoscope (OTC) Tyto Care , Ltd., IL | DQD |
| Oct 19, 2016 | K160401 | Tyto Stethoscope Tyto Care , Ltd., IL | DQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||