Stethee Pro 1, Stethee Pro Software System

K193631

M3DICINE Pty Ltd. · cleared 2020-10-09 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself. ... Additionally, successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices, as identified in the summary comparison tables above, with documentation submitted in this 510(k).”
Algorithmmachine learning analysis algorithms
source quote (p.13)
“Additionally, successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices, as identified in the summary comparison tables above, with documentation submitted in this 510(k).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“In addition to general safety and EMC testing, M3DICINE has successfully addressed FDA's requirements for wireless coexistence testing of the Stethee™ Pro 1.”

Validation studies (2)

Standalone

sample size not stated

endpoints: Heart Rate: Range of Detection and Accuracy: 30-200 BPM with an allowable readout error rate of no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less.

standards: IEC 60601-1, AAMI ES60601-1:2005 +A1, IEC 60601-1-2:2014, FDA's Guidance Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005), IEC 62304:2015

Standalone

sample size not stated

endpoints: Respiration Rate: ... accurately calculate and display respiration rates in respirations per minute for a clinically validated range of 6 - 50 breaths per minute ±1 breath per min.

standards: IEC 60601-1, AAMI ES60601-1:2005 +A1, IEC 60601-1-2:2014, FDA's Guidance Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005), IEC 62304:2015

Reported performance (2 observations)

accuracyas written: “Heart Rate Accuracy”stated without valueCI no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less.
source quote (p.10)
“30-200 BPM with an allowable readout error rate of no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less.”
accuracyas written: “Respiration Rate Accuracy”stated without valueCI ±1 breath per min.
source quote (p.10)
“Companion apps in the Stethee Pro Software accurately calculate and display respiration rates in respirations per minute for a clinically validated range of 6 - 50 breaths per minute ±1 breath per min.”

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

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
+200%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K193631