Corvair

K231010

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Corvair is Software as a Medical Device (SaMD) intended for use by healthcare professionals to analyze a diagnostic-bandwidth ECG.”
Algorithmdeep neural networks (DNNs)
source quote (p.6)
“Corvair utilizes several deep neural networks (DNNs) for its analysis.”
Adaptive (vs locked)FDA source did not state this
PCCPYes
source quote (p.8)
“As part of K231010, Corvair includes a PCCP to improve algorithm performance by retraining with additional data without modifying the architecture:”
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated · 1 site(s)

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

standards: IEC 60601-2-25

Reported performance (2 observations)

ppvas written: “PPV”stated without value
source quote (p.8)
“The comparison uses standard ECG performance metrics including, sensitivity, specificity, and PPV for the interpretive outputs”
accuracyas written: “mean absolute error for heart rate accuracy”stated without value
source quote (p.8)
“The comparison uses standard ECG performance metrics including, sensitivity, specificity, and PPV for the interpretive outputs, mean error and standard deviation of error for the interval outputs, and mean absolute error for heart rate accuracy.”

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
13
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252589 (decision 2026-01-09) from AliveCor, Inc. for a matching device line ("Corvair Monza") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252589

  • 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

  • …and 7 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/K231010