eMurmur Heart AI

K252284

Csd Labs · cleared 2025-12-19 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The eMurmur Heart AI software is a decision support system for the automated evaluation of recorded patient heart sounds.”
Algorithmautomated heart sound analysis
source quote (p.6)
“eMurmur Heart AI performs automated heart sound analysis to support users in the evaluation of heart sounds.”
Adaptive (vs locked)FDA source did not state this
PCCPYes
source quote (p.9)
“eMurmur Heart AI has an FDA-authorized Predetermined Change Control Plan (PCCP), which enables the addition of new stethoscope models for use with eMurmur Heart AI while maintaining the device's intended use, safety, and effectiveness. Modifications under the PCCP are limited to device compatibility updates and do not alter the functionality of eMurmur Heart AI.”
Cybersecurity addressedYes
source quote (p.6)
“The eMurmur backend features state-of-the-art cybersecurity features.”

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: non-inferiority for sensitivity; non-inferiority for specificity

Reported performance (3 observations)

sensitivity90CI 78.8%-95.9%
source quote (p.7)
“Sensitivity 90.0% (78.8%-95.9%)”
specificity90CI 78.8%-95.9%
source quote (p.7)
“Specificity 90.0% (78.8%-95.9%)”
accuracyas written: “Accuracy”90CI 82.8%-94.5%
source quote (p.7)
“Accuracy 90.0% (82.8%-94.5%)”

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/K252284