Cleared Traditional

Tyto Thermometer

K190242 · Tyto Care , Ltd. · General Hospital

Mar 2019

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K190242 is an FDA 510(k) clearance for the Tyto Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on March 27, 2019, 49 days after receiving the submission on February 6, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K190242 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2019
Decision Date	March 27, 2019
Days to Decision	49 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.