Cleared Traditional

Tyto Stethoscope (G3)

K252089 · Tyto Care , Ltd. · Cardiovascular
Mar 2026
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K252089 is an FDA 510(k) clearance for the Tyto Stethoscope (G3), a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on March 12, 2026, 253 days after receiving the submission on July 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number K252089 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date March 12, 2026
Days to Decision 253 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQD — Stethoscope, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1875

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