Corvair Monza

K252589

AliveCor, Inc. · cleared 2026-01-09 · product code MHX · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Corvair Monza is Software as a Medical Device (SaMD) intended for use by healthcare professionals to analyze a diagnostic-bandwidth ECG.”
Algorithmdeep neural networks (DNNs), signal processing and machine learning algorithms
source quote (p.6)
“Corvair Monza utilizes several deep neural networks (DNNs) for its analysis. Both devices use signal processing and machine learning algorithms to detect arrhythmia, perform analysis of ECG morphology, and provide interval estimates.”
Adaptive (vs locked)No
source quote (p.8)
“All algorithm modifications will be locked prior to release of the software in the field.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP), Corvair Monza Predetermined Change Control Plan, Rev. 3.”
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: sensitivity; specificity; PPV; mean error for interval outputs; standard deviation of error for interval outputs; mean absolute error for heart rate accuracy

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

50
recalls in product code, 24mo
4282
MAUDE reports in code, 12mo
+75%
vs code's own 3-yr baseline
12
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code MHX (Philips North America Llc, initiated 2026-06-05): "Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99126

  • recall_reason_pattern

    Software/algorithm-related recall in product code MHX (GE Medical Systems Information Technologies Inc, initiated 2026-04-24): "GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98938

  • recall_reason_pattern

    Software/algorithm-related recall in product code MHX (Philips North America, initiated 2025-12-22): "A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98217

  • recall_reason_pattern

    Software/algorithm-related recall in product code MHX (Philips North America Llc, initiated 2025-12-12): "It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98158

  • recall_reason_pattern

    Software/algorithm-related recall in product code MHX (Mindray DS USA, Inc. dba Mindray North America, initiated 2025-08-15): "Potential for activation of an abnormal alarm pause." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97437

  • recall_reason_pattern

    Software/algorithm-related recall in product code MHX (Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom, initiated 2025-05-30): "Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an A" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97197

  • …and 6 more.

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/K252589