Cardiovascular · 510(k) · 2024
Corvair
AliveCor, Inc.. Cleared by FDA on 7 June 2024 under submission K231010, product code MHX (monitor, physiological, patient(with arrhythmia detection or alarms)). What FDA's record says, in FDA's words.
Device record · K231010
- Device. CorvairDEVICE
- Company. AliveCor, Inc.COMPANY
- Decision. 7 June 2024, 510(k), substantially equivalent (traditional review); received 7 April 2023DECISION
- Panel. CardiovascularPANEL
- Product code. MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)CODE
- Regulation. 21 CFR 870.1025, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
AliveCor’s Corvair 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 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 analyses should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Corvair 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 33,126 reports filed against devices carrying product code MHX. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · IntelliVue MX40 1.4GHz · Philips Medical Systems · report 1218950-2026-100677
The customer reported the unit had a speaker malfunction error. It is confirmed the unit did not produce any sound at the time of the event. The device was not in use on a patient at the time of event, there was no adverse event reported.
30 September 2026 · Injury · Patient Information Center iX · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102043
It was reported that the user requested assistance in retrieving logs following the device's failure to alarm for a cardiac arrest. No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
30 September 2026 · Malfunction · IntelliVue Multi-Measurement Module X3 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102060
It was reported that the device was presented with a speaker malfunction error message and there was no sound coming from the device in standalone mode. The device was in clinical use. There was no report of patient or user harm.
30 September 2026 · Malfunction · Tempus Pro, Printer, IBP · Remote Diagnostic Technologies Ltd. · report 3003832357-2026-100556
This report is based on information provided by a Philips Remote Service Engineer, a Bench Engineer and a Technical Engineer and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus Pro, while at a Bench Repair Facility indicating that the ECG (Electrocardiography) nut was loose. There was no patient involvement, therefore no health consequences or impact.
30 September 2026 · Injury · uCor Heart Failure and Arrhythmia Management System · ZOLL Manufacturing Corporation · report 3008642652-2026-09502
A US distributor contacted ZOLL to report that the patient developed a skin irritation from the uCor HFAMS Patch. The patient described the area as a red skin irritation with burning and stinging sensation around and under the uCor HFAMS Patch. It was reported that the patient has prior history of skin sensitivity or allergies. There was no alleged device malfunction contributing to the irritation. The patient contacted their physician regarding skin irritation, but there is no indication that […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MHX, in Cardiovascular, from AliveCor, Inc., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.