510(k) · Cleared
Cleared12SL Ecg Analysis Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Aug 1, 2006 as substantially equivalent to K042177 (Ge Medical Systems Information Technologies, 2004) and 1 other predicate after a 127-day review. Its family tree reaches back 6 generations to 1993. 21 later devices descend from it.
- Decided
- Aug 1, 2006
- Review
- 127 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921669 (1993). 11 ancestors in all, the oldest K820885 (1982). 21 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 4 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 3 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 2 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 1 generation backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- This deviceK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- Descendant · cites it directly · 19 of its ownK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- Descendant · 2 generations on · 9 of its ownK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK162012 CARESCAPE Central Station V2GE Healthcare · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010 · cites it directly19descendants
- K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · 2 generations on9descendants
- K162012CARESCAPE Central Station V2GE Healthcare · 2016 · 2 generations on7descendants
- K14196312SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015 · 2 generations on6descendants
- K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −5 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −4 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −3 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −2 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −1 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| 0 (this device) | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| +1 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| +2 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| +2 | K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016 | 6 |
| +2 | K141963 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies, Inc. | 2015 | — |
| +3 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K042177 | Modification to Mac 5000 Ecg Analysis SystemSummary page 1…nalysis Program Classification Names: 21 CFR 870.1025 Monitor, Physiological Patient (with Arrhythmia Detection or Alarms) 74MHX Predicate Device: K042177 MAC 5000 EGG Analysis System K002209 12SL ECG Analysis Program Device Description: The 12S… | 2004 |
| * | K002209 | GE Marquette Ecg Analysis ProgramSummary page 1…onitor, Physiological Patient (with Arrhythmia Detection or Alarms) 74MHX Predicate Device: K042177 MAC 5000 EGG Analysis System K002209 12SL ECG Analysis Program Device Description: The 12SL EGG Analysis Program with Right Ventricular Analysis is a… | 2000 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K092369 (Ge Medical Systems Information Technologies, 2010) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K042177.
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.
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?
The 12SL ECG Analysis System with Right Ventricular Analysis assists the physician in interpreting resting 12-lead ECGs for rhythms and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of-hospital sites such as ambulances and patient's homes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060833: 12SL Ecg Analysis Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060833
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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