510(k) · Cleared
ClearedCorvair Monza
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AliveCor, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 9, 2026 as substantially equivalent to K231010 (AliveCor, Inc., 2024) after a 147-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Jan 9, 2026
- Review
- 147 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921669 (1993). 15 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations between
- 3 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 2 generations backK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- 1 generation backK231010 CorvairAliveCor, Inc. · 2024
- This deviceK252589 Corvair MonzaAliveCor, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 9 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 8 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 7 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 6 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 5 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 4 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 3 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 2 generations backK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- 1 generation backK231010 CorvairAliveCor, Inc. · 2024
- This deviceK252589 Corvair MonzaAliveCor, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −9 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −8 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −7 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −6 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −5 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −4 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| −3 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| −2 | K141963 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies, Inc. | 2015 | — |
| −1 | K231010 | Corvair | AliveCor, Inc. | 2024 | — |
| 0 (this device) | K252589 | Corvair Monza | AliveCor, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231010 | CorvairSummary page 5…ulation 21 CFR§ 870.1025 Device Class II Product Code MHX Predicate Information [807.92(a)(3)] Predicate(s) K231010, Corvair by AliveCor Inc. Device Description [807.92(a)(4)] Corvair Monza is Software as a Medical Device (SaMD) intended for us… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
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…
Read the full statement (159 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252589: Corvair Monza.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252589
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026