Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Tyto Care with 9 510(k) clearances and 7 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 2, 2026: Tyto Insights for Wheeze Detection (with PCCP).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 2, 2026 | Tyto Insights for Wheeze Detection (with PCCP)K252844 · PHZ | 510(k) clearances |
| Jun 2, 2026 | Tyto Insights for Wheeze Detection (with PCCP)K252844 · Anesthesiology | AI-enabled devices |
| Mar 17, 2026 | Tyto Insights for Eardrum Bulging DetectionDEN250014 · SHL | 510(k) clearances |
| Mar 17, 2026 | Tyto Insights for Eardrum Bulging DetectionDEN250014 · Ear Nose & Throat | AI-enabled devices |
| Mar 12, 2026 | Tyto Stethoscope (G3)K252089 · DQD | 510(k) clearances |
| Mar 12, 2026 | Tyto Stethoscope (G3)K252089 · Cardiovascular | AI-enabled devices |
| Apr 7, 2025 | Tyto Insights for Rhonchi DetectionK243567 · PHZ | 510(k) clearances |
| Apr 7, 2025 | Tyto Insights for Rhonchi DetectionK243567 · Anesthesiology | AI-enabled devices |
| Jul 2, 2024 | Tyto Insights for Crackles DetectionK240555 · PHZ | 510(k) clearances |
| Jul 2, 2024 | Tyto Insights for Crackles DetectionK240555 · Anesthesiology | AI-enabled devices |
| Dec 13, 2023 | Tyto Insights for Wheeze DetectionK232237 · PHZ | 510(k) clearances |
| Dec 13, 2023 | Tyto Insights for Wheeze DetectionK232237 · Anesthesiology | AI-enabled devices |
| Feb 24, 2023 | TytoCare Lung Sounds AnalyzerK221614 · PHZ | 510(k) clearances |
| Mar 27, 2019 | Tyto ThermometerK190242 · FLL | 510(k) clearances |
| Oct 19, 2016 | Tyto StethoscopeK160401 · Cardiovascular | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
