FDA 510(k) · AliveCor
K252589: Corvair Monza (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K252589 for Corvair Monza, with a decision date of Jan 9, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K252589 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | Corvair Monza |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Aug 15, 2025 |
| Decision date | Jan 9, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
[807.92(a)(5)] AliveCor’s Corvair Monza ECG analysis system assists the healthcare professional (HCP) in measuring and interpreting resting diagnostic ECGs for rhythm and morphological information by providing an initial automated interpretation. The interpretation by the analysis program may then be confirmed, edited, or deleted by the HCP. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. Corvair Monza is intended for use by healthcare professionals, or trained personnel in healthcare facilities (e.g. the doctor’s office or hospital) and in acute settings. Corvair Monza analyses should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Corvair Monza analyses are considered unconfirmed and must be reviewed by a qualified physician. The provisional automated ECG analysis should not be used for clinical action if it has not been reviewed by a qualified healthcare professional capable of independently interpreting the ECG signal. Substantial Equivalence
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K231010 Corvair (AliveCor)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.