Stethophone Pro

K252595

Sparrow Acoustics, Inc. · cleared 2025-09-12 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Stethophone Pro is an electronic stethoscope software application that operates on smartphones.”
AlgorithmThe software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur.
source quote (p.5)
“The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur.”
Adaptive (vs locked)No
source quote (p.8)
“The acoustics algorithms for sound filtering (that are used for both OTC and Rx parts of the software) capabilities remain entirely unchanged from those validated and cleared in both K240901 and K231551. Automated sound analysis capabilities (that are available for Rx use only) remain entirely unchanged from those validated and cleared in K240901.”
PCCPNo
Cybersecurity addressedNo

Validation studies (0)

FDA source did not describe a validation study.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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/K252595