eMurmur Heart AI

K220766

CSD Labs GmbH · cleared 2022-05-31 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The 'eMurmur Heart Al' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur. For eMurmur Heart Al, only the relevant component, i.e., the algorithm analyzing heart sounds, is treated as a medical device. The other components which are solely intended to transfer, store, convert and display medical data or results are excluded from the scope of the medical device.”
Algorithmheart sound analysis algorithm
source quote (p.5)
“Both systems use the same heart sound analysis algorithm, hosted on a server, requiring a 20 second digital heart sound recording and the patient's age as input.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“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 (0)

FDA source did not describe a validation study.

Reported performance (2 observations)

sensitivity85CI 72.9%-92.5%
source quote (p.7)
“Sensitivity: 85.0% (72.9%-92.5%)”
specificity86.7CI 74.9%-93.7%
source quote (p.7)
“Specificity: 86.7% (74.9%-93.7%)”

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
1
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

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/K220766