Tyto Stethoscope (G3)— 510(k) K252089

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K252089 for Tyto Stethoscope (G3), Substantially Equivalent on 2026-03-12. Applicant: Tyto Care , Ltd.. Device class: 2.

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2025-07-02
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQD

K261494 — Smart Wireless Stethoscope (4 models)2026-07-31
K261694 — CORE 300 Digital Stethoscope2026-07-23
K252915 — AiSteth®2026-05-22
K252076 — Kneevoice Cartilage Evaluation System (750-3600-001)2026-02-06
K252284 — eMurmur Heart AI2025-12-19

More clearances from Tyto Care , Ltd.

K252844 — Tyto Insights for Wheeze Detection (with PCCP)2026-06-02
DEN250014 — Tyto Insights for Eardrum Bulging Detection2026-03-17
K243567 — Tyto Insights for Rhonchi Detection2025-04-07
K240555 — Tyto Insights for Crackles Detection2024-07-02
K232237 — Tyto Insights for Wheeze Detection2023-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.