510(k) · Cleared
ClearedCorvair
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 Jun 7, 2024 as substantially equivalent to K141963 (Ge Medical Systems Information Technologies, Inc., 2015) after a 427-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Jun 7, 2024
- Review
- 427 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921669 (1993). 14 ancestors in all, the oldest K820885 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations between
- 3 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 2 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 1 generation backK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- This deviceK231010 CorvairAliveCor, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252589 Corvair MonzaAliveCor, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 8 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 7 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 6 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 5 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 4 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 3 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 2 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 1 generation backK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- This deviceK231010 CorvairAliveCor, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K252589Corvair MonzaAliveCor, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −8 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −7 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −6 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −5 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −4 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −3 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| −2 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| −1 | K141963 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies, Inc. | 2015 | — |
| 0 (this device) | K231010 | Corvair | AliveCor, Inc. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K141963 | 12SL Ecg Analysis ProgramSummary page 5…ulation 21 CFR§ 870.1025 Device Class II Product Code MHX Predicate Information [807.92(a)(3)] Predicate(s) K141963, 12SL ECG Analysis Program by GE Medical Systems® Device Description [807.92(a)(4)] Corvair is Softw… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252589 | Corvair Monza | 2026 | 0 |
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 31 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K252589 (AliveCor, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K141963.
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. 2024, 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 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 (155 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231010 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231010: Corvair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231010
Report an extraction error
Are you the manufacturer?
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