510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250014Unknown

Tyto Insights for Eardrum Bulging Detection

Tyto Care Inc., Netanya, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN250014 is the FDA 510(k) clearance record for Tyto Insights for Eardrum Bulging Detection, a class II device, cleared for Tyto Care , Ltd. on under FDA product code SHL (Ear, Nose, And Throat Image Analyzer). FDA's definition for product code SHL reads: "An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or...". FDA records list 10 510(k) clearances for Tyto Care , Ltd., from to . As of , FDA records show no recalls naming DEN250014.

Clearance record

Decision date
Received
(330 days to decision)
Product code
SHL Ear, Nose, And Throat Image Analyzer
Regulation
21 CFR 874.4775
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Tyto Care , Ltd. 14 Beni Gaon St., Netanya, IL
Third party review
No

Clearances, product code SHL

Trailing 12 months
2 clearances under product code SHL in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260