eMurmur ID

K181988

CSD Labs GmbH · cleared 2019-04-17 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“eMurmur ID is a software system comprised of the following components: 1. The eMurmur ID Backend, running on a server environment, hosts the eMurmur ID Heart Sound Analysis Algorithm, an encrypted database for archiving patient and user information, and an application programming interface (API) for communication with the web portal and mobile application. 2. The eMurmur ID Mobile App, which runs on a mobile device. The app permits the following activities: a. Electronic recording of heart sound signals via a compatible electronic stethoscope, the Littmann 3200 b. Visual and acoustic playback of heart and lung sounds c. Capturing patient information d. Transferring data to and from the eMurmur ID backend through a secure connection e. Displaying heart sound analysis results 3. The eMurmur ID Web Portal, which provides the following functionalities: a. Capturing and editing patient information b. Displaying and editing patient encounters including heart sound analysis results c. Visual and acoustic playback of heart and lung sounds d. Downloading reports (PDF) and heart and lung sound recordings e. Transferring data to and from the eMurmur ID backend through a secure connection”
AlgorithmHeart Sound Analysis Algorithm
source quote (p.2)
“The eMurmur ID Heart Sound Analysis Algorithm”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.5)
“Encrypted internet traffic, data stored in the database on the backend is encrypted, data in the database is duplicated to another database in a different datacenter, no protected health information is stored on the user's devices, user needs to authenticate, user can only access authorized data”

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

n=120 patients

endpoints: sensitivity; specificity; accuracy

Reported performance (3 observations)

sensitivity0.85CI 72.9%-92.5%
source quote (p.6)
“Sensitivity (95% CI) 85.0% (72.9%-92.5%)”
specificity0.867CI 74.9%-93.7%
source quote (p.6)
“Specificity (95% CI) 86.7% (74.9%-93.7%)”
accuracyas written: “Accuracy”0.858CI 78.0%-91.3%
source quote (p.6)
“Accuracy (95% CI) 85.8% (78.0%-91.3%)”

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
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252284 (decision 2025-12-19) from Csd Labs for a matching device line ("eMurmur Heart AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252284

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220766 (decision 2022-05-31) from CSD Labs GmbH for a matching device line ("eMurmur Heart AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K220766

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/K181988