Tyto Stethoscope (G3)
K252089Tyto Care , Ltd. · cleared 2026-03-12 · product code DQD · Cardiovascular
Premarket evidence — what FDA accepted
source quote (p.6)
“The Tyto Stethoscope (G3) system is designed for use by lay users in non-clinical environments to capture auscultation sounds for transmission to a clinician for review. It enables three types of stethoscope exams: Heart, Lungs and Heart Rate. The Tyto Stethoscope (G3) system is a multiple functions system, the operation process of the system uses four (4) primary functional elements: (1) The Tyto Stethoscope (composed of a TytoCare Device with Stethoscope adaptor supported with proprietary TytoCare Device App software). The TytoCare Device App contains device software functions. ... Software changes include updated firmware to support new hardware, user interface refinements, and the inclusion of AI-enabled algorithms for heart rate calculation and recording quality feedback (A reference device was included to support that an AI-enabled algorithm designed for the analysis of stethoscope recordings was previously cleared by the FDA (K220766).”
source quote (p.10)
“AI enabled algorithm”
source quote (p.11)
“Cybersecurity- all the applicable information to reflect effective cybersecurity management and to address the FDA's recommendations described in Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems”
Validation studies (3)
Retrospective clinical
n=200 other
endpoints: Accuracy was defined as the algorithm's HR measurement matching the reference value within ±5 beats per minute (BPM) or 10% (whichever is greater) across the 30–250 BPM range.
standards: IEC 60601-1 Edition 3.2 2020-08, 60601-1-11 Edition 2.1 2020-07, IEC 60601-1-2 Edition 4.1 2020-09, IEC TR 60601-4-2 Edition 1.0 2016-05, ISO 10993-1:2018, ISO 14971:2019, ISO 17664:2021, AAMI TIR12:2020 (R2023), AAMI ST98:2022
Bench
sample size not stated
endpoints: frequency response (FR); maximum input level; noise level
Retrospective clinical
sample size not stated
endpoints: accuracy of the heart and lung recording quality assessment algorithms in determining whether sound recordings captured with the Tyto Stethoscope are of sufficient quality for clinical assessment.
Reported performance (1 observation)
source quote (p.13)
“The algorithm achieved 100% accuracy (98.1–100% confidence interval) across all cases, exceeding the predefined primary endpoint threshold of 90%.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).