Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012678246

FEI Number

3012678246

Entity Name

TYTOCARE LTD.

City/State/Country

Netanya Central, IL

Establishment Address

14 Beni Gaon St., Netanya Central 4250803, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tytocare Ltd. (Owner Number: 10052860)

Owner / Operator Contact Address

14 Beni Gaon St., Netanya, IL-NOTA 4250803, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181612

PMA Number

N/A

All Registered Proprietary Names

Tyto Insights for Wheeze Detection Tyto Insights for Rhonchi Detection Tyto Insights for Crackles Detection Tyto Insights for Wheeze Detection TytoCare Pulse Oximeter Tongue depressor Tyto Insights for Eardrum Bulging Detection

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2016-10-13
PHZ	Abnormal Breath Sound Device	Anesthesiology	Class 2	868.1900	2023-12-19
PHZ	Abnormal Breath Sound Device	Anesthesiology	Class 2	868.1900	2025-05-06
PHZ	Abnormal Breath Sound Device	Anesthesiology	Class 2	868.1900	2024-09-26
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2016-10-13
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2016-10-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-04-04
PHZ	Abnormal Breath Sound Device	Anesthesiology	Class 2	868.1900	2023-05-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-28
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2020-12-27
SHL	Ear, Nose, And Throat Image Analyzer	Ear, Nose, Throat	Class 2	874.4775	2026-05-04
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2018-12-24

Official Correspondent

Stella Raizelman Perry

US Agent Details

Patrick Delos Reyes Email: patrickd@tytocare.com Phone: (866) 9718986

Related Public Records

Same Entity

Tytocare Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K771506	Swartz Medical Equipment	STETHOSCOPE	1977-08-26
K082528	Noble Anesthesia-Air, Inc.	SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM	2009-03-06
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3024680050	FIREFLY VEIN LIGHT LLC	Chattanooga, TN, US
3015438293	MACQUARIE MEDICAL SYSTEMS PVT. LTD	Leichhardt New South Wales, AU
3012499069	CANFIELD SCIENTIFIC, INC.	Parsippany, NJ, US
1421873	XEMAX SURGICAL PRODUCTS, INC.	NAPA, CA, US
3009424883	FIREFLY GLOBAL	Belmont, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012678246. Last updated year: 2026. Please use registration number 3012678246 when referencing this establishment in official correspondence.