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Tytocare Ltd.: FDA-registered device maker in Netanya Central, Israel, 10 510(k) clearances

Name: Tytocare Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tytocare Ltd. is registered with the FDA (registration 3012678246) in Netanya Central, Israel. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012678246
Address: 14 Beni Gaon St., Netanya Central, Israel, 4250803
Owner or operator: Tytocare Ltd. (10052860)
Roles: Exporter to the US, Manufacturer
First device listed: October 13, 2016
Registered through: 2026
Brand names listed: Tongue depressor, Tyto Insights for Crackles Detection, Tyto Insights for Eardrum Bulging Detection, Tyto Insights for Rhonchi Detection, Tyto Insights for Wheeze Detection, Tyto Insights for Wheeze Detection (with PCCP), TytoCare Pulse Oximeter

Devices it lists

Device	Product code	Class	Role	Source
Abnormal Breath Sound Device	PHZ	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Manufacturer	accessdata.fda.gov
Ear, Nose, And Throat Image Analyzer	SHL	2	Manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 2, 2026	K252844	Tyto Insights for Wheeze Detection (with PCCP)	PHZ	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
March 17, 2026	DEN250014	Tyto Insights for Eardrum Bulging Detection	SHL	Unknown	Tyto Care , Ltd.	accessdata.fda.gov
April 7, 2025	K243567	Tyto Insights for Rhonchi Detection	PHZ	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
July 2, 2024	K240555	Tyto Insights for Crackles Detection	PHZ	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
December 13, 2023	K232237	Tyto Insights for Wheeze Detection	PHZ	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
February 24, 2023	K221614	TytoCare Lung Sounds Analyzer	PHZ	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
March 27, 2019	K190242	Tyto Thermometer	FLL	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
December 17, 2018	K181612	Tyto Stethoscope (OTC)	DQD	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
October 19, 2016	K160401	Tyto Stethoscope	DQD	Substantially Equivalent	Tyto Care , Ltd.	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov

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Updated June 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.