Tyto Care Inc.
New York, NY, US
TYTO CARE INC. appears in FDA device records in New York, NY. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Tyto Care Inc. between 2016 and 2026. The busiest year on record is 2026, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | PHZ | Substantially Equivalent | |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | SHL | Unknown | |
| K252089 | Tyto Stethoscope (G3) | DQD | Substantially Equivalent | |
| K243567 | Tyto Insights for Rhonchi Detection | PHZ | Substantially Equivalent | |
| K240555 | Tyto Insights for Crackles Detection | PHZ | Substantially Equivalent | |
| K232237 | Tyto Insights for Wheeze Detection | PHZ | Substantially Equivalent | |
| K221614 | TytoCare Lung Sounds Analyzer | PHZ | Substantially Equivalent | |
| K190242 | Tyto Thermometer | FLL | Substantially Equivalent | |
| K181612 | Tyto Stethoscope (OTC) | DQD | Substantially Equivalent | |
| K160401 | Tyto Stethoscope | DQD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012679006 | 3012679006 | TYTO CARE INC. | 264 West 40th St., New York, NY 10018 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain