# Tyto Care, Ltd.

- Location (FDA's records): Netanya, IL
- FDA decisions: 10 (2016–2026): 9 510(k) clearances and 1 De Novo grant
- Product codes: PHZ (5), DQD (3), SHL (1), FLL (1)
- 510(k) review time since 2016: median 216 days, against 217 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 15 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rnk Products, Inc.: 1 (https://510kreport.com/company/rnk-products)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Stethocloud Pty.Ltd (Clinicloud): 1 (https://510kreport.com/company/stethocloud-clinicloud)
- Respiri Limited: 1 (https://510kreport.com/company/respiri)
- Kaz USA, Inc (A Subsidiaryof Kaz Inc): 1 (https://510kreport.com/company/kaz-usa-a-subsidiaryof-kaz)

## Firms that cite its devices most
- Nonagon, Ltd.: 2 (https://510kreport.com/company/nonagon)
- Myhomedoc, Ltd.: 1 (https://510kreport.com/company/myhomedoc)
- Withings: 1 (https://510kreport.com/company/withings)
- Heartbuds, LLC: 1 (https://510kreport.com/company/heartbuds)
- Eko Devices, Inc.: 1 (https://510kreport.com/company/eko-devices)
- Medaica, Inc.: 1 (https://510kreport.com/company/medaica)
- Ironsides Medical, Inc.: 1 (https://510kreport.com/company/ironsides-medical)
- Aevice Health Pte., Ltd.: 1 (https://510kreport.com/company/aevice-health)

## Its most-cited devices
- K181612: Tyto Stethoscope (OTC) (2018), cited by 6
- K232237: Tyto Insights for Wheeze Detection (2023), cited by 3
- K160401: Tyto Stethoscope (2016), cited by 2
- DEN250014: Tyto Insights for Eardrum Bulging Detection (2026), cited by 1
- K221614: TytoCare Lung Sounds Analyzer (2023), cited by 1
- K190242: Tyto Thermometer (2019), cited by 1

## Recent decisions
- K252844: Tyto Insights for Wheeze Detection (with PCCP) (Jun 2, 2026)
- DEN250014: Tyto Insights for Eardrum Bulging Detection (Mar 17, 2026)
- K252089: Tyto Stethoscope (G3) (Mar 12, 2026)
- K243567: Tyto Insights for Rhonchi Detection (Apr 7, 2025)
- K240555: Tyto Insights for Crackles Detection (Jul 2, 2024)
- K232237: Tyto Insights for Wheeze Detection (Dec 13, 2023)
- K221614: TytoCare Lung Sounds Analyzer (Feb 24, 2023)
- K190242: Tyto Thermometer (Mar 27, 2019)

Source page: https://510kreport.com/company/tyto-care