Impala

K232035

AliveCor, Inc. · cleared 2024-06-07 · product code DPS · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 standard diagnostic-bandwidth ECG leads from a patient (I, II, V1 or V2, V4), derives 4 standard diagnostic-bandwidth leads (aVL, aVR, aVF, III), and using software generates the remaining leads (V2 or V1, V3, V5, V6) to create a 12-Lead ECG recording. The Impala hardware consists of the Impala ECG Module that connects to the Patient Lead Wire. The Patient Lead Wire is a single cable that includes five snap-on electrodes. Impala also consists of a mobile software application, the Impala App that executes on a mobile computing platform (MCP), such as an Apple iPhone smartphone. Impala utilizes a machine learning model for lead synthesis. Impala incorporates AliveCor's Corvair (K231010), a software as a medical device, to provide rhythm analysis, morphological analysis, and ECG measurements.”
AlgorithmMachine learning model for lead synthesis; Software as a Medical Device (SaMD) for rhythm and morphological analysis.
source quote (p.6)
“Impala utilizes a machine learning model for lead synthesis. Impala incorporates AliveCor's Corvair (K231010), a software as a medical device, to provide rhythm analysis, morphological analysis, and ECG measurements.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (5)

Bench

sample size not stated

endpoints: Conformance to IEC standards

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-1-11, IEC 60601-1-12

Bench

sample size not stated

endpoints: Conformance to ANSI EC53

standards: ANSI EC53

Bench

sample size not stated

endpoints: Satisfies design, hardware, and software requirements

Bench

n=3,000 images · 1 site(s)

endpoints: Evaluation of 4 synthesized chest leads in comparison with corresponding chest leads of a standard 10-electrode resting 12-lead ECG; Similarity of synthesized leads to corresponding 12-leads

standards: IEC 60601-2-25

Bench

sample size not stated

endpoints: Usability of the device, including data collection and understanding data presented on the App

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

9
recalls in product code, 24mo
72
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
3
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Braemar Manufacturing, LLC, initiated 2024-12-18): "Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95837

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Baxter Healthcare Corporation, initiated 2024-10-11): "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95559

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Schiller, Ag Altgasse 68 Baar Switzerland, initiated 2024-07-24): "Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95074

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/K232035